Cognitive Training and Dual-task Ability
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01895608
Collaborator
(none)
34
2
4
26
17
0.7
Study Details
Study Description
Brief Summary
The first goal of this study is to examine the extent to which the inclusion of dual-task practice to standard balance rehabilitation results in greater benefits to dual-task ability. The second goal of this study is to examine the extent to which the addition of cognitive training following balance rehabilitation results in greater benefits to dual-task ability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Historically, degradation of balance control in older adults has been attributed to impairments of the motor and/or sensory systems. As a result, therapy has focused on motor and sensory impairments. However, evidence suggests that an impaired ability to allocate attentional resources to balance during dual-task situations is a powerful predictor of falls. Despite this fact, few studies have examined whether interventions can improve older adults' dual-task ability. The goal of this study is to develop effective interventions to improve ability to allocate attention to balance and gait under dual-task conditions.
Older adults (n = 44) who have been referred to physical therapy (PT) for gait or balance impairments who have dual-task impairment will be randomized to receive either standard balance rehabilitation or balance rehabilitation with dual-task practice. Following PT, subjects will receive cognitive training (CT), either speed of processing or generalized cognitive training. Primary outcomes are ability to walk while performing four different cognitive tasks of varying difficulty. Assessment will occur at baseline, post-PT, post-CT.
Study Design
Study Type:
Interventional
Actual Enrollment
:
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cognitive Training and Dual-task Ability in Older Adults
Study Start Date
:
Jul 1, 2013
Actual Primary Completion Date
:
Sep 1, 2015
Actual Study Completion Date
:
Sep 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Balance rehabilitation + dual-tasking Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. |
Behavioral: Balance rehabilitation + dual-tasking
Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant
|
| Active Comparator: Standard balance rehabilitation Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. |
Behavioral: Standard balance rehabilitation
Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
|
| Experimental: Cognitive training (speed of processing) Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. |
Behavioral: Cognitive training (speed of processing)
Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
|
| Active Comparator: Cognitive training (general cognition) General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
Behavioral: Cognitive training (general cognition)
General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
|
Outcome Measures
Primary Outcome Measures
- Change Scores in Timed up and go With Cognitive Task [baseline and 6 weeks]
Timed up and go test (TUG) has three conditions: no secondary task (TUG), cognitive (TUGc) and manual dual-tasks (TUG-m). Time to complete the task with the cognitive task was recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability.
Secondary Outcome Measures
- Change Scores in Walk While Talk Test With Verbal Fluency Task [baseline and 6 weeks]
The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.
- Change Scores in Dynamic Gait Index [baseline and 6 weeks]
Dynamic Gait Index (DGI) assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability. Each of the 8 conditions is scored on a scale from 0 (indicating severe impairment) to 3 (indicating normal ability). The total score is used for statistical analysis with a maximum score of 24 and a minimum score of 0 with a higher score indicating better performance. A total DGI score less than 20 out of 24 indicates fall risk.
- Change Scores in Sensory Organization Test (SOT) [baseline and 6 weeks]
SOT is organized into a series of 6 conditions of increasing difficulty: 3 involve a firm surface with eyes open, eyes closed and with vision sway-referenced and 3 involve a sway-referenced surface with eyes open, eyes closed, and with vision sway-referenced. SOT has good reliability and differentiates fallers and nonfallers. The SOT composite score is used for statistical analysis with a maximum score of 100 (indicating perfect stability) and a minimum score of 0 (indicating severe instability). Higher scores indicate better performance (i.e., greater postural stability) and SOT composite scores less than 38 out of 100 indicate fall risk.
- Change Scores in Preferred Gait Speed [baseline and 6 weeks]
Subjects walk at their preferred speed and time to walk 6 m is recorded.
- Change Scores in Activities-specific Balance-related Confidence [baseline and 6 weeks]
Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability. Sixteen activities are each assessed on a scale ranging from 0 to 100, where higher scores indicate greater confidence in performing the activity. Item scores are averaged to arrive at a final score, where average scores <67% indicate a greater fall risk.
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Inclusion criteria include:
-
60 years of age
-
documented balance or mobility problems
-
dual-task impairment (timed up and go with subtraction task > 15 s)
Exclusion Criteria:
-
Exclusion criteria include:
-
cognitive impairment (> 2 errors on Short Portable Mental Status Questionnaire41)
-
progressive medical issues that would impact mobility (e.g., Parkinson's disease).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | United States | 30033 |
| 2 | Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN | Mountain Home | Tennessee | United States | 37684 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Courtney D Hall, PhD PT, Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01895608
Other Study ID Numbers:
- E7614-P
First Posted:
Jul 10, 2013
Last Update Posted:
Jun 19, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by VA Office of Research and Development
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Period Title: Overall Study | ||||
| STARTED | 10 | 7 | 11 | 6 |
| COMPLETED | 10 | 6 | 8 | 6 |
| NOT COMPLETED | 0 | 1 | 3 | 0 |
Baseline Characteristics
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. | Total of all reporting groups |
| Overall Participants | 10 | 7 | 11 | 6 | 34 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
77.0
(8.3)
|
81.9
(7.9)
|
78.1
(6.7)
|
80.7
(11.1)
|
79.0
(8.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
8
80%
|
0
0%
|
5
45.5%
|
3
50%
|
16
47.1%
|
| Male |
2
20%
|
7
100%
|
6
54.5%
|
3
50%
|
18
52.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
10
100%
|
7
100%
|
11
100%
|
6
100%
|
34
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
10%
|
0
0%
|
0
0%
|
1
16.7%
|
2
5.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
10%
|
1
14.3%
|
2
18.2%
|
0
0%
|
4
11.8%
|
| White |
8
80%
|
6
85.7%
|
9
81.8%
|
5
83.3%
|
28
82.4%
|
| 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 (participants) [Number] | |||||
| United States |
10
100%
|
7
100%
|
11
100%
|
6
100%
|
34
100%
|
Outcome Measures
| Title | Change Scores in Timed up and go With Cognitive Task |
|---|---|
| Description | Timed up and go test (TUG) has three conditions: no secondary task (TUG), cognitive (TUGc) and manual dual-tasks (TUG-m). Time to complete the task with the cognitive task was recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability. |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Measure Participants | 10 | 6 | 8 | 6 |
| Mean (Standard Deviation) [seconds] |
-0.89
(3.36)
|
-0.37
(2.24)
|
-0.64
(1.62)
|
-1.42
(1.92)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balance Rehabilitation + Dual-task Practice, Standard Balance Rehabilitation |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistic: Mann-Whitney U test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.562 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cognitive Training (Speed of Processing), Cognitive Training (General Cognition) |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.414 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Title | Change Scores in Walk While Talk Test With Verbal Fluency Task |
|---|---|
| Description | The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task. |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Measure Participants | 10 | 6 | 8 | 6 |
| Mean (Standard Deviation) [seconds] |
1.76
(3.48)
|
-3.83
(9.66)
|
-2.73
(4.67)
|
3.01
(10.04)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balance Rehabilitation + Dual-task Practice, Standard Balance Rehabilitation |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.181 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cognitive Training (Speed of Processing), Cognitive Training (General Cognition) |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change Scores in Dynamic Gait Index |
|---|---|
| Description | Dynamic Gait Index (DGI) assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability. Each of the 8 conditions is scored on a scale from 0 (indicating severe impairment) to 3 (indicating normal ability). The total score is used for statistical analysis with a maximum score of 24 and a minimum score of 0 with a higher score indicating better performance. A total DGI score less than 20 out of 24 indicates fall risk. |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Measure Participants | 10 | 6 | 8 | 6 |
| Mean (Standard Deviation) [units on a scale] |
2.50
(2.07)
|
1.50
(4.64)
|
-0.38
(1.92)
|
0.00
(2.45)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balance Rehabilitation + Dual-task Practice, Standard Balance Rehabilitation |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cognitive Training (Speed of Processing), Cognitive Training (General Cognition) |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.662 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change Scores in Sensory Organization Test (SOT) |
|---|---|
| Description | SOT is organized into a series of 6 conditions of increasing difficulty: 3 involve a firm surface with eyes open, eyes closed and with vision sway-referenced and 3 involve a sway-referenced surface with eyes open, eyes closed, and with vision sway-referenced. SOT has good reliability and differentiates fallers and nonfallers. The SOT composite score is used for statistical analysis with a maximum score of 100 (indicating perfect stability) and a minimum score of 0 (indicating severe instability). Higher scores indicate better performance (i.e., greater postural stability) and SOT composite scores less than 38 out of 100 indicate fall risk. |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Measure Participants | 10 | 6 | 8 | 6 |
| Mean (Standard Deviation) [units on a scale] |
6.44
(12.03)
|
-1.50
(5.65)
|
-0.50
(20.28)
|
8.60
(6.19)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balance Rehabilitation + Dual-task Practice, Standard Balance Rehabilitation |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cognitive Training (Speed of Processing), Cognitive Training (General Cognition) |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.171 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change Scores in Preferred Gait Speed |
|---|---|
| Description | Subjects walk at their preferred speed and time to walk 6 m is recorded. |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Measure Participants | 10 | 6 | 8 | 6 |
| Mean (Standard Deviation) [meters per second] |
0.07
(0.29)
|
0.24
(0.40)
|
0.05
(0.51)
|
0.16
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balance Rehabilitation + Dual-task Practice, Standard Balance Rehabilitation |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.313 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cognitive Training (Speed of Processing), Cognitive Training (General Cognition) |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.852 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change Scores in Activities-specific Balance-related Confidence |
|---|---|
| Description | Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability. Sixteen activities are each assessed on a scale ranging from 0 to 100, where higher scores indicate greater confidence in performing the activity. Item scores are averaged to arrive at a final score, where average scores <67% indicate a greater fall risk. |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) |
|---|---|---|---|---|
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. |
| Measure Participants | 10 | 6 | 8 | 6 |
| Mean (Standard Deviation) [overall percentage of confidence] |
10.70
(14.44)
|
3.16
(7.04)
|
-0.31
(7.88)
|
-8.59
(13.62)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balance Rehabilitation + Dual-task Practice, Standard Balance Rehabilitation |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.263 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cognitive Training (Speed of Processing), Cognitive Training (General Cognition) |
|---|---|---|
| Comments | Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training. | |
| Type of Statistical Test | Other | |
| Comments | non-parametric statistical analysis: Mann Whitney U Test for independent samples | |
| Statistical Test of Hypothesis | p-Value | 0.181 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Adverse Events
| Time Frame | 12 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) | ||||
| Arm/Group Description | Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task. Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. | Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field. | General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation. | ||||
All Cause Mortality |
||||||||
| Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Fall | 0/10 (0%) | 0 | 1/6 (16.7%) | 1 | 0/8 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
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. Courtney Hall |
|---|---|
| Organization | James H Quillen VAMC |
| Phone | 423-926-1171 ext 7518 |
| courtney.hall@va.gov |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01895608
Other Study ID Numbers:
- E7614-P
First Posted:
Jul 10, 2013
Last Update Posted:
Jun 19, 2017
Last Verified:
Apr 1, 2017