- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895608
Cognitive Training and Dual-task Ability
Cognitive Training and Dual-task Ability in Older Adults
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Tennessee
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Mountain Home, Tennessee, United States, 37684
- Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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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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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.
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Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Scores in Timed up and go With Cognitive Task
Time Frame: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Scores in Walk While Talk Test With Verbal Fluency Task
Time Frame: baseline and 6 weeks
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The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.
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baseline and 6 weeks
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Change Scores in Dynamic Gait Index
Time Frame: baseline and 6 weeks
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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
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Change Scores in Sensory Organization Test (SOT)
Time Frame: baseline and 6 weeks
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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
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Change Scores in Preferred Gait Speed
Time Frame: baseline and 6 weeks
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Subjects walk at their preferred speed and time to walk 6 m is recorded.
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baseline and 6 weeks
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Change Scores in Activities-specific Balance-related Confidence
Time Frame: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E7614-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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