Reminiscence Technology Balance and Mobility
Sponsor
Bruyere Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04043416
Collaborator
(none)
28
1
2
7.6
3.7
Study Details
Study Description
Brief Summary
This study evaluates the feasibility of a larger randomized controlled trial to examine the effect of reminiscence aided physical activity on the balance and mobility of older adults living in long term care. The study uses the jDome BikeAround system, which is a stationary bicycle with a projector screen that runs google earth, as the user bicycles, the map progresses giving the appearance that the user is bicycling through the environment chosen. Half of the participants will use the system during the first 6 week campaign, there will then be a 6 week washout period. Following the washout period, there will be a second 6 week campaign when the other half of the participants will use the jDome BikeAround system.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Physical activity has been shown to have numerous benefits for physical well-being and function. Stationary cycling is one example of physical activity that can provide opportunities for residents who are inactive, living in long term care and are at high risk for falls.
The use of jDome BikeAround provides older adults in long term care an opportunity to engage in a motivating reminiscence activity that is coupled with physical activity. Participants will be divided into two groups, one group will take part in jDome BikeAround sessions 3x per week for 6 weeks in addition to The Glebe Centre's Fall Prevention program, while the second group will just participant in Fall Prevention program. There will be a 6 week wash out, then the second cohort will participant in the jDome Bike Around sessions 3x a week in addition to the Fall Prevention program while the first cohort will just participate in the Fall Prevention Program.
Participants will have their balance, mobility, leg strength, endurance tested as well as a tracking of fall risks at the beginning and end of each of the jDome BikeAround sessions (4 measurement points). Feasibility will be determined by the ability to enroll an adequate number of participants, protocol completion by participants, and the number of adverse events.
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This study has 2 six week campaigns with a six week washout in between the 2 campaigns. During the first campaign half of the participants will use the motivating reminiscence technology while receiving the standard fall prevention programming, while the second half will receive just the standard fall prevention programming. During the 6 week washout period all participants will just receive the standard fall prevention programming. After the washout period, there will be the second campaign where the other half of the participants will use the motivating reminiscence technology while receiving the standard fall prevention programming, whereas the remaining participants will just receive the standard fall prevention programming.This study has 2 six week campaigns with a six week washout in between the 2 campaigns. During the first campaign half of the participants will use the motivating reminiscence technology while receiving the standard fall prevention programming, while the second half will receive just the standard fall prevention programming. During the 6 week washout period all participants will just receive the standard fall prevention programming. After the washout period, there will be the second campaign where the other half of the participants will use the motivating reminiscence technology while receiving the standard fall prevention programming, whereas the remaining participants will just receive the standard fall prevention programming.
Masking:
Single (Outcomes Assessor)
Masking Description:
All outcome measures will be collected by the physiotherapy team at The Glebe Centre. The physiotherapy team will be blinded to the group allocation of each participant.
Primary Purpose:
Treatment
Official Title:
Using Motivating Reminiscence Technology to Encourage Physical Activity and Improve Balance and Mobility for Residents in Long Term Care
Actual Study Start Date
:
May 13, 2019
Actual Primary Completion Date
:
Nov 18, 2019
Actual Study Completion Date
:
Dec 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: System + Fall Prevention First, then Fall Prevention Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation. |
Other: Motivating reminiscence technology
The jDome BikeAround uses Google Street View, a stationary bike and a domed screen. Residents are seated in front of the screen; their destination is typed into the computer and when loaded the image appears on the screen. Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish.
Other Names:
|
| Experimental: Fall Prevention first, then System +Fall Prevention Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation. |
Other: Motivating reminiscence technology
The jDome BikeAround uses Google Street View, a stationary bike and a domed screen. Residents are seated in front of the screen; their destination is typed into the computer and when loaded the image appears on the screen. Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Recruited [Baseline]
Determine the feasibility of a future randomized controlled trial to evaluate the impact on balance and mobility of motivating reminiscence technology using the jDome BikeAround system for adults in long term care. Feasibility will be determined by the ability to recruit 30 residents (based on the LTC population base at The Glebe Centre).
- Protocol Adherence [Week 18]
Determine the feasibility of a future randomized controlled trial to evaluate the impact on balance and mobility of motivating reminiscence technology using the jDome BikeAround system for adults in long term care. Feasibility will be determined by the number of residents to complied with the protocol during their respective campaign by using the jDome BikeAround system 3 times a week.
- Number of Participants Who Experience an Adverse Events While Using the jDome BikeAround (System) [Week 18]
The number of adverse events while directly interacting with the jDome BikeAround system will be tracked to help determine feasibility of this kind of randomized trial.
- Performance Oriented Mobility Assessment [Baseline]
The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This will give us a baseline value for the participants.
- Performance Oriented Mobility Assessment [Week 6]
The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken after the first campaign has been completed.
- Performance Oriented Mobility Assessment [Week 12]
The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken just before the second campaign is to begin.
- Performance Oriented Mobility Assessment [Week 18]
The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken after the second campaign has been completed.
Secondary Outcome Measures
- 2 Minute Walk Test [Baseline]
Distance participant can walk without assistance for 2 minutes measured from the starting position.
- 2 Minute Walk Test [6 Week]
Distance participant can walk without assistance for 2 minutes measured from the starting position.
- 2 Minute Walk Test [12 Week]
Distance participant can walk without assistance for 2 minutes measured from the starting position.
- 2 Minute Walk Test [18 Week]
Distance participant can walk without assistance for 2 minutes measured from the starting position.
- Knee Range of Motion Test [Baseline]
Test that asses the range of motion of a participant's knee
- Knee Range of Motion Test [6 weeks]
Test that asses the range of motion of a participant's knee
- Knee Range of Motion Test [12 weeks]
Test that asses the range of motion of a participant's knee
- Knee Range of Motion Test [18 weeks]
Test that asses the range of motion of a participant's knee
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Scott fall risk of 2-17 (this is the current range used by the Glebe Centre, there have been 0 falls during transportation to the equipment and during each session of the BikeAround system)
-
Sufficient visual abilities to observe images on the domed screen
-
Able to comprehend and communicate in English.
-
Adequate attentional capacity to remain focused on the pedalling task.
-
Minimum height requirement of 5'2" or 157cm in order to successfully fit the BikeAround system's stationary bike.
Exclusion Criteria:
-
Physical limitations (as determined by the Glebe Centre healthcare/physiotherapy team) that prevent use of the jDome bike.
-
Cognitive impairment (as determined by the Glebe Centre healthcare/physiotherapy team) Inability to sustain attention Inability to follow one-step commands.
-
Known behavioural abnormalities (e.g. overly aggressive behavior) that in the opinion of the clinical care team might impede any meaningful participation in the project
-
Those who are in the opinion of attending physician or clinical team too unwell to participate in the project
-
Fully unable to complete outcome measures indicated (Section 7, Outcomes)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Glebe Centre | Ottawa | Ontario | Canada | K1S 5A7 |
Sponsors and Collaborators
- Bruyere Research Institute
Investigators
- Principal Investigator: Mark Campbell, MD, MSc, Bruyere Continuing Care
Study Documents (Full-Text)
More Information
Publications
- Batcir S, Melzer I. Daily Bicycling in Older Adults May be Effective to Reduce Fall Risks-A Case-Control Study. J Aging Phys Act. 2018 Oct 1;26(4):570-576. doi: 10.1123/japa.2017-0263. Epub 2018 Aug 29.
- Benjamin K, Edwards N, Ploeg J, Legault F. Barriers to physical activity and restorative care for residents in long-term care: a review of the literature. J Aging Phys Act. 2014 Jan;22(1):154-65. doi: 10.1123/japa.2012-0139. Epub 2013 Feb 20. Review.
- de Hollander EL, Proper KI. Physical activity levels of adults with various physical disabilities. Prev Med Rep. 2018 Apr 24;10:370-376. doi: 10.1016/j.pmedr.2018.04.017. eCollection 2018 Jun.
- Harvey S, Rissel C, Pijnappels M. Associations Between Bicycling and Reduced Fall-Related Physical Performance in Older Adults. J Aging Phys Act. 2018 Jul 1;26(3):514-519. doi: 10.1123/japa.2017-0243. Epub 2018 Jun 22.
- Huang HC, Chen YT, Chen PY, Huey-Lan Hu S, Liu F, Kuo YL, Chiu HY. Reminiscence Therapy Improves Cognitive Functions and Reduces Depressive Symptoms in Elderly People With Dementia: A Meta-Analysis of Randomized Controlled Trials. J Am Med Dir Assoc. 2015 Dec;16(12):1087-94. doi: 10.1016/j.jamda.2015.07.010. Epub 2015 Sep 1.
- Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12. Review.
- Lautenschlager NT, Cox K, Kurz AF. Physical activity and mild cognitive impairment and Alzheimer's disease. Curr Neurol Neurosci Rep. 2010 Sep;10(5):352-8. doi: 10.1007/s11910-010-0121-7. Review.
- Macaluso A, Young A, Gibb KS, Rowe DA, De Vito G. Cycling as a novel approach to resistance training increases muscle strength, power, and selected functional abilities in healthy older women. J Appl Physiol (1985). 2003 Dec;95(6):2544-53. Epub 2003 Aug 22.
- Menne HL, Johnson JD, Whitlatch CJ, Schwartz SM. Activity Preferences of Persons With Dementia. Activities, Adaptation & Aging, 36(3): 195-213, 2012. DOI: 10.1080/01924788.2012.696234
- Varela S, Cancela JM, Seijo-Martinez M, Ayán C. Self-Paced Cycling Improves Cognition on Institutionalized Older Adults Without Known Cognitive Impairment: A 15-Month Randomized Controlled Trial. J Aging Phys Act. 2018 Oct 1;26(4):614-623. doi: 10.1123/japa.2017-0135. Epub 2018 Sep 8.
- Vogel T, Brechat PH, Leprêtre PM, Kaltenbach G, Berthel M, Lonsdorfer J. Health benefits of physical activity in older patients: a review. Int J Clin Pract. 2009 Feb;63(2):303-20. doi: 10.1111/j.1742-1241.2008.01957.x. Review.
Responsible Party:
Mark Campbell,
Clinician-Investigator and Associate Staff Physician,
Bruyere Research Institute
ClinicalTrials.gov Identifier:
NCT04043416
Other Study ID Numbers:
- M16-19-012
First Posted:
Aug 2, 2019
Last Update Posted:
Aug 7, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mark Campbell,
Clinician-Investigator and Associate Staff Physician,
Bruyere Research Institute
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | System+Fall Prevention First, Then Fall Prevention Alone | Fall Prevention First, Then System+Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation. |
| Period Title: Campaign 1 | ||
| STARTED | 14 | 14 |
| COMPLETED | 14 | 14 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Campaign 1 | ||
| STARTED | 14 | 14 |
| COMPLETED | 14 | 13 |
| NOT COMPLETED | 0 | 1 |
| Period Title: Campaign 1 | ||
| STARTED | 14 | 13 |
| COMPLETED | 14 | 13 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention | Total |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround uses Google Street V | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Motivating reminiscence technology: The jDome BikeAround uses Google Street V | Total of all reporting groups |
| Overall Participants | 14 | 14 | 28 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
87.7
(9.9)
|
79.9
(9.1)
|
84.0
(10.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
11
78.6%
|
11
78.6%
|
22
78.6%
|
| Male |
3
21.4%
|
3
21.4%
|
6
21.4%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Canada |
14
100%
|
13
92.9%
|
27
96.4%
|
| Scott Fall Risk (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.1
(4.7)
|
8.9
(5.3)
|
8.0
(5.0)
|
| Cognitive Performance Scale (CPS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3
(0.8)
|
3
(1.3)
|
3
(1.1)
|
| Index for Social Engagement (ISE) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
5
(1.3)
|
5
(1.2)
|
5
(1.3)
|
Outcome Measures
| Title | Number of Participants Recruited |
|---|---|
| Description | Determine the feasibility of a future randomized controlled trial to evaluate the impact on balance and mobility of motivating reminiscence technology using the jDome BikeAround system for adults in long term care. Feasibility will be determined by the ability to recruit 30 residents (based on the LTC population base at The Glebe Centre). |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround uses Google Street V | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Motivating reminiscence technology: The jDome BikeAround uses Google Street V |
| Measure Participants | 14 | 14 |
| Count of Participants [Participants] |
14
100%
|
14
100%
|
| Title | Protocol Adherence |
|---|---|
| Description | Determine the feasibility of a future randomized controlled trial to evaluate the impact on balance and mobility of motivating reminiscence technology using the jDome BikeAround system for adults in long term care. Feasibility will be determined by the number of residents to complied with the protocol during their respective campaign by using the jDome BikeAround system 3 times a week. |
| Time Frame | Week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround uses Google Street V | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Motivating reminiscence technology: The jDome BikeAround uses Google Street V |
| Measure Participants | 14 | 13 |
| Count of Participants [Participants] |
2
14.3%
|
4
28.6%
|
| Title | Number of Participants Who Experience an Adverse Events While Using the jDome BikeAround (System) |
|---|---|
| Description | The number of adverse events while directly interacting with the jDome BikeAround system will be tracked to help determine feasibility of this kind of randomized trial. |
| Time Frame | Week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround uses Google Street V | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Motivating reminiscence technology: The jDome BikeAround uses Google Street V |
| Measure Participants | 14 | 13 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Performance Oriented Mobility Assessment |
|---|---|
| Description | The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This will give us a baseline value for the participants. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| To complete this test, the participant must have a certain level of mobility. Out of the 14 participants in the "System + Fall Prevention First, then Fall Prevention" cohort, 4 couldn't complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 10 | 14 |
| Mean (Standard Deviation) [units on a scale] |
19.6
(2.9)
|
21.6
(3.7)
|
| Title | Performance Oriented Mobility Assessment |
|---|---|
| Description | The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken after the first campaign has been completed. |
| Time Frame | Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| To complete this test, the participant must have a certain level of mobility. Out of the 14 participants in the "Motivating reminiscence technology + Fall Prevention" cohort, 3 couldn't complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 11 | 13 |
| Mean (Standard Deviation) [units on a scale] |
16.8
(6.5)
|
19.6
(6.7)
|
| Title | Performance Oriented Mobility Assessment |
|---|---|
| Description | The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken just before the second campaign is to begin. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| To complete this test, the participant must have a certain level of mobility. Out of the 14 participants in the "System + Fall Prevention First, then Fall Prevention" cohort, 5 couldn't complete the test and 2 participant out of the 13 participants in the 'Fall Prevention first, then System +Fall Prevention' cohort that could not complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 9 | 11 |
| Mean (Standard Deviation) [units on a scale] |
16.5
(7.6)
|
19.7
(7.6)
|
| Title | Performance Oriented Mobility Assessment |
|---|---|
| Description | The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken after the second campaign has been completed. |
| Time Frame | Week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| To complete this test, the participant must have a certain level of mobility. Out of the 14 participants in the "System + Fall Prevention First, then Fall Prevention" cohort, 5 couldn't complete the test and 1 participant out of the 13 in the 'Fall Prevention first, then System +Fall Prevention' cohort that could not complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 9 | 12 |
| Mean (Standard Deviation) [units on a scale] |
17
(6.8)
|
19
(7.6)
|
| Title | 2 Minute Walk Test |
|---|---|
| Description | Distance participant can walk without assistance for 2 minutes measured from the starting position. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inability to ambulate for 2 minutes independently, in the arm "System + Fall Prevention First, then Fall Prevention" 4 residents were unable to complete the test and 2 residents in the "Fall Prevention first, then System +Fall Prevention" were unable to complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 10 | 12 |
| Mean (Standard Deviation) [Meter] |
60.9
(26.5)
|
84.7
(55.1)
|
| Title | 2 Minute Walk Test |
|---|---|
| Description | Distance participant can walk without assistance for 2 minutes measured from the starting position. |
| Time Frame | 6 Week |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inability to ambulate for 2 minutes independently, in the arm "System + Fall Prevention First, then Fall Prevention" 4 residents were unable to complete the test and 2 residents in the "Fall Prevention first, then System +Fall Prevention" were unable to complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 10 | 12 |
| Mean (Standard Deviation) [Meter] |
72.4
(9.1)
|
67.6
(27.1)
|
| Title | 2 Minute Walk Test |
|---|---|
| Description | Distance participant can walk without assistance for 2 minutes measured from the starting position. |
| Time Frame | 12 Week |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inability to ambulate for 2 minutes independently, in the arm "System + Fall Prevention First, then Fall Prevention" 4 residents were unable to complete the test and 2 residents in the "Fall Prevention first, then System +Fall Prevention" were unable to complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 10 | 11 |
| Mean (Standard Deviation) [Meter] |
70.7
(27.1)
|
68.6
(31.8)
|
| Title | 2 Minute Walk Test |
|---|---|
| Description | Distance participant can walk without assistance for 2 minutes measured from the starting position. |
| Time Frame | 18 Week |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inability to ambulate for 2 minutes independently, in the arm "System + Fall Prevention First, then Fall Prevention" 4 residents were unable to complete the test and 2 residents in the "Fall Prevention first, then System +Fall Prevention" were unable to complete the test. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 10 | 11 |
| Mean (Standard Deviation) [Meter] |
54.5
(32.5)
|
67.6
(27.1)
|
| Title | Knee Range of Motion Test |
|---|---|
| Description | Test that asses the range of motion of a participant's knee |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 participants in the "Fall Prevention first, then System +Fall Prevention" could not have their knee range of motion measures. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 14 | 12 |
| Left Knee Extension |
-3.2
(5.8)
|
-2.9
(4.3)
|
| Right Knee Extension |
-3.6
(8.5)
|
-2.7
(4.2)
|
| Left Knee Flexion |
111.6
(12.4)
|
109.3
(12.6)
|
| Right Knee Flexion |
107.2
(17.8)
|
106.1
(13.7)
|
| Title | Knee Range of Motion Test |
|---|---|
| Description | Test that asses the range of motion of a participant's knee |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 participants in the "Fall Prevention first, then System +Fall Prevention" could not have their knee range of motion measures. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 14 | 12 |
| Left Knee Extension |
-1.4
(5.3)
|
-5
(8.5)
|
| Right Knee Extension |
-2.1
(8.0)
|
-4.2
(7.6)
|
| Left Knee Flexion |
114.6
(16.6)
|
115.0
(9.5)
|
| Right Knee Flexion |
115.7
(14.7)
|
116.7
(9.8)
|
| Title | Knee Range of Motion Test |
|---|---|
| Description | Test that asses the range of motion of a participant's knee |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participants in the "System + Fall Prevention First, then Fall Prevention" could not have their knee range of motion measures. |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 13 | 13 |
| Left Knee Extension |
0
(6.9)
|
-1.25
(4.3)
|
| Right Knee Extension |
-2.3
(8.3)
|
-1.7
(5.8)
|
| Left Knee Flexion |
118.8
(11.0)
|
116.5
(15.7)
|
| Right Knee Flexion |
116.5
(13.8)
|
116.7
(16.3)
|
| Title | Knee Range of Motion Test |
|---|---|
| Description | Test that asses the range of motion of a participant's knee |
| Time Frame | 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention |
|---|---|---|
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program |
| Measure Participants | 14 | 13 |
| Left Knee Extension |
0
(0)
|
0
(0)
|
| Right Knee Extension |
-0.7
(2.7)
|
-3.5
(7.7)
|
| Left Knee Flexion |
110.4
(13.4)
|
111.9
(10.7)
|
| Right Knee Flexion |
111.4
(11.3)
|
108.8
(11.2)
|
Adverse Events
| Time Frame | 18 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention | ||
| Arm/Group Description | Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Motivating reminiscence technology: The jDome BikeAround uses Google Street V | Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Motivating reminiscence technology: The jDome BikeAround uses Google Street V | ||
All Cause Mortality |
||||
| System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/13 (0%) | ||
Serious Adverse Events |
||||
| System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/13 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| System + Fall Prevention First, Then Fall Prevention | Fall Prevention First, Then System +Fall Prevention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/13 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Katherine Reilly |
|---|---|
| Organization | The University of Ottawa |
| Phone | 613-562-5800 ext 8238 |
| kreilly@uottawa.ca |
Responsible Party:
Mark Campbell,
Clinician-Investigator and Associate Staff Physician,
Bruyere Research Institute
ClinicalTrials.gov Identifier:
NCT04043416
Other Study ID Numbers:
- M16-19-012
First Posted:
Aug 2, 2019
Last Update Posted:
Aug 7, 2020
Last Verified:
Jul 1, 2020