TeleBATRAC: Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format
Study Details
Study Description
Brief Summary
Loss of arm use and strength are common problems after stroke that greatly affects independence in activities of daily living. Arm rehabilitation using robot-assisted repetitive task training has shown to improve motor recovery. However, this type of exercise cannot be done at home as these devices are large and expensive. This study will test whether a more portable, less costly, non-robotic repetitive training device called Bilateral Arm Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation format will lead to improvement in arm and hand use in patients with chronic stroke. The investigators plan to test the effectiveness of home based tele-rehabilitation with the BATRAC compared to a home and a clinic based approach.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a longitudinal, single blind, randomized controlled trial with three parallel 6 week intervention arms that will be conducted over a three-year time period. After obtaining informed consent, and completing baseline testing, participants will be randomized to one of three study arms: 1) Home-based BATRAC Telerehab (HBT) + TTT, 2) Lab-based BATRAC (LBB) + TTT, and 3) Delayed Entry Usual Care. This delayed entry group will serve as a control for the initial six weeks of enrollment and NOT receive an active study intervention before randomizing to one of the two active interventions. Weekly phone calls will be conducted during this control period to record general activity (household or community) and monitor amount and intensity of arm use.
Participants will complete Home-based BATRAC training or Lab-based BATRAC training three times a week for 6-9 weeks for a total of 18 training sessions. Participants will then be asked to return for a follow-up after 8 weeks of no training. A study evaluator blinded to the intervention assignment will complete all outcome measures at baseline, training completion, and at the 8 week retention follow-up. The participants in the Home-based BATRAC telerehabilitation group will be given a VA's MyHealtheVet (www.myhealth.va.gov) website account for asynchronous communication with the therapist and to access the educational features and resources about stroke, exercise and caregiver support. The interventions are as described below.
- Home-based BATRAC telerehabilitation: The BATRAC training platform will be used in conjunction with the VA MyHealtheVet website. This group will have a MyHealtheVet account to access the Secure Messaging Option for VA approved electronic messaging to the study therapist. The MyHealtheVet will provide asynchronous communication with the study therapist, and will store performance information entered by the participant and caregiver related to arm exercise duration, repetitions completed and distances reached. This account can be securely linked and is VA approved for use on any home device (computer, cell phone or tablet) with internet. MyHealtheVet training will be completed at the VA and at a one-time home visit with the participant and their identified caregiver to verify access, and use.
BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest periods (see Lab-based BATRAC training details below) followed by 15 minutes of video guided Transition to Task Training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos demonstrating the exercise. The initial training will occur in the lab setting with the therapist for BATRAC instruction and TTT exercise training. The participant and caregiver will have the opportunity ask questions and develop proficiency during this training session. For the TTT, each functional task will be presented via the MyHealtheVet Secure Messaging (SM) and linked by a URL to an instructive Youtube video clip of exercise sequencing, and level of difficulty. After completion of each exercise session the participant will complete a study report form attached to the SM. This information will be available for off-line assessment of performance by the research therapist. In cases of participant non-adherence, the therapist can contact the participant via phone to review exercise barriers and motivate the individual to participate. If necessary, the therapist could change the exercise parameters and send changes within the My HealtheVet SM.
- Lab-based BATRAC + TTT training: Participants randomized to this group will receive 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). The BATRAC training consists of high intensity bilateral reaching and retrieving (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. The track can be set at different angles in the work space. The training protocol is the same for both groups and will consist of four, 5-minute periods interspersed with 5-minute rest periods to avoid fatigue. An auditory metronome is set initially at the participant's preferred speed and for periods 1 and 3 participants move both arms simultaneously (in-phase). In periods 2 and 4 participants move both arms in alternating (antiphase) movements. A fifth bout of simultaneous arm movements will be included to reach the 45 minute training goal. Progression of the auditory cue frequency, direction of travel (pushing/pulling or in a diagonal) and distance of reach will be progressed every 2 weeks based on performance. If a progression cannot be sustained for the five-minute bouts by the end of the session, adjustments towards the previous level are made. This training will be followed by 15 minutes of transition to task training (TTT) as described below with supervision and support as needed by the therapist.
Transition to Task Training (TTT): Each participant will receive 45 minutes of their randomized BATRAC intervention followed by 15 minutes of TTT. This training is functionally based in four domains of real-world tasks: homemaking, hygiene, feeding, and dressing. Two goal directed functional tasks are selected from the four domains every two weeks and prescribed to the individual based on severity level, general interests and goal. The task design is progressive in nature and difficulty is added by changing the parameters (movement amplitude) and demand (resistance) for increased generalization to real life challenges. Assist by the therapist or caregiver is provided to prevent compensatory movements from being re-enforced. For the home-based training, the caregiver will be instructed to provide this assistance through the initial personal training as well as have access to a set of videos for each of the tasks.
- Delayed Entry Usual Care: Participants randomized to this group will initially serve as a control and not receive any study interventions except for the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level. After serving as a control, this group will be entered into their delayed active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home-Based BATRAC Home-based BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system. |
Device: Home-Based BATRAC plus TTT
Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.
|
| Experimental: Lab-based BATRAC plus TTT Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and rest periods followed by 15 minutes of therapist guided transition to task training (TTT). |
Device: Lab-based BATRAC plus TTT
Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist.
|
| Placebo Comparator: Delayed Entry Usual Care Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They will also receive weekly phone calls to record general activity level. After serving as a control, this group will be entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
Behavioral: Delayed Entry Usual Care
Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level.
|
Outcome Measures
Primary Outcome Measures
- Wolf Motor Function Test Performance Time (WMFT) [Final Training (week 6)]
The change between WMFT performance time from baseline to post-training was analyzed. Change = 6week WMFT log (time) minus baseline WMFT log (time). The WMFT performance time is a measure of movement speed to complete fifteen timed tasks up to a maximum of 120 seconds. A faster time (lower value) indicates a better outcome. The WMFT logarithm transformed time (WMFT log (time)) mean values were analyzed to reduce the skewness of the WMFT time values. The primary study outcome was the between group difference in the Home-based WMFT log (time) post-training compared to the control.
Secondary Outcome Measures
- Fugl-Meyer Assessment Scale-Upper Extremity [Final Training (week 6)]
The Fugl-Meyer Assessment scale is a stroke specific motor impairment measure. It provides an assessment of graded volitional arm tasks and hand movements using a scale ranging from 0-66 where a higher score indicates a better outcome. It has been shown to be valid, reliable and have high inter-rater reliability and test/retest reliability.
- Stroke Impact Scale (SIS)-Hand Domain [Final Training (week 6)]
The Stroke Impact Scale is self-reported structured interview consisting of eight domains examining the physical, mental, and emotional changes that occur after a stroke and contribute to a change in quality of life. The SIS has been tested and found to be reliable, valid, and sensitive to change in the stroke population. It has four physical domains which assess strength, activities of daily living (ADL), mobility, and hand function abilities post stroke. These domains can be analyzed separately and scored on a 0-100 scale where a higher score indicates a better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 years or older
-
Have a clinically defined unilateral hemiparetic stroke with radiologic exclusion of other diagnosis
-
Stroke onset of at least 6 months prior to enrollment
-
Present with moderate to severe arm impairment based on a Fugl-Meyer score ranging from 19-50 out of 66
-
No previous experience using the BATRAC
-
Ability to use and interact with the tele-rehabilitation platform according to study protocol
-
Have an identified individual/caregiver to perform the TTT exercises if randomized to the Home Telerehabilitation group
Exclusion Criteria:
-
Musculoskeletal diagnosis or significant arm pain that would interfere with positioning and use of the intervention (BATRAC) devices
-
Cognitive impairment such that the participant is unable to understand the study requirements to answer the Evaluation to Sign Consent Form tool accurately
-
Absence of a working telephone line or cell phone for telerehabilitation set-up if randomized to this group
-
Enrollment in a concurrent rehabilitation study or actively receiving therapy for their stroke affected (study) arm
-
Having received a botulinum toxin injection to the stroke affected (study) arm within 3 months of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Susan S Conroy, DSc PT, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study Documents (Full-Text)
More Information
Publications
None provided.- B1828-R
Study Results
Participant Flow
| Recruitment Details | Community-dwelling adults with chronic hemiparetic arm disability were recruited from the VA Maryland Health Care System, University of Maryland Medical System, and community between May 2017 and July 2019. |
|---|---|
| Pre-assignment Detail | Of 63 enrolled participants, 44 were study trial participants and 19 were participant caregivers for the home-based group. Of the 44 study trial participants, 15 did not meet inclusion criteria resulting in 29 individuals randomized into the study. |
| Arm/Group Title | Home-based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care | Home-based BATRAC Caregivers |
|---|---|---|---|---|
| Arm/Group Description | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. | Lab-based BATRAC + TTT consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. | An identified caregiver provided assistance as needed for the home-based intervention. |
| Period Title: Overall Study | ||||
| STARTED | 11 | 9 | 9 | 19 |
| COMPLETED | 8 | 7 | 9 | 14 |
| NOT COMPLETED | 3 | 2 | 0 | 5 |
Baseline Characteristics
| Arm/Group Title | Home-based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care | Home-based BATRAC Caregivers | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of video guided transition to task training (TTT). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist guided transition to task training (TTT). | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did received weekly phone calls to record general activity level. After serving as a control, this group entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. | An identified caregiver provided assistance as needed for the home-based intervention. | Total of all reporting groups |
| Overall Participants | 11 | 9 | 9 | 19 | 48 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
64.7
(8.6)
|
58.1
(10.6)
|
58.7
(9.4)
|
59.2
(17.1)
|
60.1
(11.4)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
5
45.5%
|
4
44.4%
|
4
44.4%
|
11
57.9%
|
24
50%
|
| Male |
6
54.5%
|
5
55.6%
|
5
55.6%
|
8
42.1%
|
24
50%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
7
63.6%
|
8
88.9%
|
6
66.7%
|
12
63.2%
|
33
68.8%
|
| White |
4
36.4%
|
1
11.1%
|
3
33.3%
|
7
36.8%
|
15
31.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||
| United States |
11
100%
|
9
100%
|
9
100%
|
19
100%
|
48
100%
|
| Wolf Motor Function Test Performance Time (log (seconds)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log (seconds)] |
3.2
(0.3)
|
3.3
(0.4)
|
3.2
(0.4)
|
3.2
(0.4)
|
|
| Fugl-Meyer (units on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [units on a scale] |
32.3
(9.5)
|
34.8
(12.1)
|
32.2
(9.1)
|
33
(9.9)
|
|
| Stroke Impact Scale-hand domain (units on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [units on a scale] |
28.2
(22.9)
|
32.2
(35.7)
|
40
(25.6)
|
33.1
(27.7)
|
|
Outcome Measures
| Title | Wolf Motor Function Test Performance Time (WMFT) |
|---|---|
| Description | The change between WMFT performance time from baseline to post-training was analyzed. Change = 6week WMFT log (time) minus baseline WMFT log (time). The WMFT performance time is a measure of movement speed to complete fifteen timed tasks up to a maximum of 120 seconds. A faster time (lower value) indicates a better outcome. The WMFT logarithm transformed time (WMFT log (time)) mean values were analyzed to reduce the skewness of the WMFT time values. The primary study outcome was the between group difference in the Home-based WMFT log (time) post-training compared to the control. |
| Time Frame | Final Training (week 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 24 participants were included in the analysis, as we excluded patients who had no 6-week follow-up data on the primary outcome. |
| Arm/Group Title | Home-Based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care |
|---|---|---|---|
| Arm/Group Description | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The BATRAC training included high intensity bilateral reaching and rest periods. The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except for protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
| Measure Participants | 8 | 7 | 9 |
| Mean (Standard Deviation) [log (seconds)] |
3.6
(1.0)
|
2.9
(1.2)
|
3.1
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Home-Based BATRAC, Delayed Entry Usual Care |
|---|---|---|
| Comments | 78 participants were needed to generate a sample size of 22 per group and provide 80% power to detect a between group difference in mean Wolf time change (6 week - baseline) based on an a priori assumption of a mean change of 0 and 7.4 seconds respectively for the delayed entry usual care control and home-based BATRAC group; a SD of 7.6 and discontinuation rate of 15%. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | The primary analysis was a two sample t-test (alpha=0.05) of the mean WMFT log-time change at 6 weeks. The threshold for statistical significance was p-value = 0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Fugl-Meyer Assessment Scale-Upper Extremity |
|---|---|
| Description | The Fugl-Meyer Assessment scale is a stroke specific motor impairment measure. It provides an assessment of graded volitional arm tasks and hand movements using a scale ranging from 0-66 where a higher score indicates a better outcome. It has been shown to be valid, reliable and have high inter-rater reliability and test/retest reliability. |
| Time Frame | Final Training (week 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 24 participants completed the 6-week post-training evaluations and were included in the analysis. |
| Arm/Group Title | Home-Based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care |
|---|---|---|---|
| Arm/Group Description | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
| Measure Participants | 8 | 7 | 9 |
| Mean (Standard Deviation) [score on a scale] |
32.3
(10.6)
|
40.7
(13.5)
|
32.0
(9.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Home-Based BATRAC, Lab-based BATRAC Plus TTT, Delayed Entry Usual Care |
|---|---|---|
| Comments | Within group changes from baseline to week 6 were assessed using analysis of variance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | The lab-based group had significant within group mean Fugl-Meyer (FM) change at week 6. | |
| Method | ANOVA | |
| Comments | Dunnett's adjustments were used to compare the active intervention changes to the delayed-entry usual care control group. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Home-Based BATRAC, Delayed Entry Usual Care |
|---|---|---|
| Comments | FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Stroke Impact Scale (SIS)-Hand Domain |
|---|---|
| Description | The Stroke Impact Scale is self-reported structured interview consisting of eight domains examining the physical, mental, and emotional changes that occur after a stroke and contribute to a change in quality of life. The SIS has been tested and found to be reliable, valid, and sensitive to change in the stroke population. It has four physical domains which assess strength, activities of daily living (ADL), mobility, and hand function abilities post stroke. These domains can be analyzed separately and scored on a 0-100 scale where a higher score indicates a better outcome. |
| Time Frame | Final Training (week 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 24 participants completed the 6-week post-training evaluations and were included in the analysis. |
| Arm/Group Title | Home-Based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care |
|---|---|---|---|
| Arm/Group Description | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
| Measure Participants | 8 | 7 | 9 |
| Mean (Standard Deviation) [score on a scale] |
31.9
(33.1)
|
45.0
(26.5)
|
39.4
(30.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Home-Based BATRAC, Delayed Entry Usual Care |
|---|---|---|
| Comments | Within group SIS hand changes from baseline to week 6 were assessed using analysis of variance followed by comparisons to the delayed-entry usual care control using Dunnett's adjustment. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.31 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | 14 to 20 weeks for each subject depending on randomization 14 weeks if randomized directly to intervention (6 weeks training + 8 weeks post training follow up). 20 weeks if randomized to delayed entry control (6 weeks control + 6 weeks training + 8 weeks post training). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse event reporting reflects the combined *total* number that received each intervention. Therefore, Home-Based BATRAC and Lab-Based BATRAC plus TTT listed below includes the delayed entry subject's AE's while randomized to each respective training group. | |||||||
| Arm/Group Title | Home-based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care | Home-based BATRAC Caregivers | ||||
| Arm/Group Description | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of video guided transition to task training (TTT). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. | An identified caregiver provided assistance as needed for the home-based intervention. | ||||
All Cause Mortality |
||||||||
| Home-based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care | Home-based BATRAC Caregivers | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/14 (0%) | 0/9 (0%) | 0/19 (0%) | ||||
Serious Adverse Events |
||||||||
| Home-based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care | Home-based BATRAC Caregivers | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/14 (0%) | 0/9 (0%) | 0/19 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Home-based BATRAC | Lab-based BATRAC Plus TTT | Delayed Entry Usual Care | Home-based BATRAC Caregivers | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/15 (26.7%) | 4/14 (28.6%) | 1/9 (11.1%) | 0/19 (0%) | ||||
| Cardiac disorders | ||||||||
| Cardiac Issues | 0/15 (0%) | 0 | 0/14 (0%) | 0 | 1/9 (11.1%) | 1 | 0/19 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Fall at home | 3/15 (20%) | 3 | 0/14 (0%) | 0 | 0/9 (0%) | 0 | 0/19 (0%) | 0 |
| Arm pain | 0/15 (0%) | 0 | 1/14 (7.1%) | 1 | 0/9 (0%) | 0 | 0/19 (0%) | 0 |
| Back pain | 0/15 (0%) | 0 | 1/14 (7.1%) | 1 | 0/9 (0%) | 0 | 0/19 (0%) | 0 |
| Chest pain | 0/15 (0%) | 0 | 1/14 (7.1%) | 1 | 0/9 (0%) | 0 | 0/19 (0%) | 0 |
| Social circumstances | ||||||||
| Dehydration and not taking medications | 1/15 (6.7%) | 1 | 1/14 (7.1%) | 1 | 0/9 (0%) | 0 | 0/19 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Dr. Susan S. Conroy |
|---|---|
| Organization | Baltimore VA Medical Center VA Maryland Health Care System |
| Phone | (410) 637-3213 |
| susan.conroy@va.gov |
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