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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balance rehabilitation + dual-tasking | Experimental | 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. |
|
| Standard balance rehabilitation | Active Comparator | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. |
|
| Cognitive training (speed of processing) | Experimental | 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 (general cognition) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance rehabilitation + dual-tasking | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change Scores in Timed up and go With Cognitive Task | 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. | baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change Scores in Walk While Talk Test With Verbal Fluency Task | The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task. | baseline and 6 weeks |
| Change Scores in Dynamic Gait Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney D Hall, PhD PT | Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | United States | ||
| Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| FG003 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Scores in Timed up and go With Cognitive Task | 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. | Posted | Mean | Standard Deviation | seconds | baseline and 6 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant fell during the assessment visit while on a break between tasks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney Hall | James H Quillen VAMC | 423-926-1171 | 7518 | courtney.hall@va.gov |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Standard balance rehabilitation | Behavioral | Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands. |
|
| Cognitive training (speed of processing) | Behavioral | 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 (general cognition) | Behavioral | 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. |
|
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.
| baseline and 6 weeks |
| Change Scores in Sensory Organization Test (SOT) | 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. | baseline and 6 weeks |
| Change Scores in Preferred Gait Speed | Subjects walk at their preferred speed and time to walk 6 m is recorded. | baseline and 6 weeks |
| Change Scores in Activities-specific Balance-related Confidence | 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. | baseline and 6 weeks |
| Mountain Home |
| Tennessee |
| 37684 |
| United States |
| Withdrawal by Subject |
|
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | 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. 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
| OG003 | 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. 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. |
|
|
|
| Secondary | Change Scores in Walk While Talk Test With Verbal Fluency Task | The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task. | Posted | Mean | Standard Deviation | seconds | baseline and 6 weeks |
|
|
|
|
| Secondary | Change Scores in Dynamic Gait Index | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 weeks |
|
|
|
|
| Secondary | Change Scores in Sensory Organization Test (SOT) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 weeks |
|
|
|
|
| Secondary | Change Scores in Preferred Gait Speed | Subjects walk at their preferred speed and time to walk 6 m is recorded. | Posted | Mean | Standard Deviation | meters per second | baseline and 6 weeks |
|
|
|
|
| Secondary | Change Scores in Activities-specific Balance-related Confidence | 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. | Posted | Mean | Standard Deviation | overall percentage of confidence | baseline and 6 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. 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. | 0 | 6 | 1 | 6 |
| EG002 | 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. 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. | 0 | 8 | 0 | 8 |
| EG003 | 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. 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. | 0 | 6 | 0 | 6 |
|
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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. |
| Wilcoxon (Mann-Whitney) |
| 1.000 |
| Other |
non-parametric statistical analysis: Mann Whitney U Test for independent samples |
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. |
| Wilcoxon (Mann-Whitney) |
| 0.662 |
| Other |
non-parametric statistical analysis: Mann Whitney U Test for independent samples |
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. |
| Wilcoxon (Mann-Whitney) |
| 0.171 |
| Other |
non-parametric statistical analysis: Mann Whitney U Test for independent samples |
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. |
| Wilcoxon (Mann-Whitney) |
| 0.852 |
| Other |
non-parametric statistical analysis: Mann Whitney U Test for independent samples |
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. |
| Wilcoxon (Mann-Whitney) |
| 0.181 |
| Other |
non-parametric statistical analysis: Mann Whitney U Test for independent samples |