- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02280928
Development and Evaluation of a Home-Based Dual-Task Training Program to Improve Balance Performance for Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Although, dual-task motor-cognitive training has proven to be more effective in improving dual-task balance performance than traditional single-task motor training, poor evidence of training-related transfer to a novel dual task has been shown. Additionally, another important impediment to the development of intervention to improve dual-task balance performance is that the previous studies have largely focused on training in a laboratory, or clinical setting, often with one-on-one supervision by a therapist or research assistant. Even though the home-based approach is more pragmatic, desirable, and encourages accessibility, no study has been done to examine the efficacy of home-based dual-task training.
Therefore, this study aims to address these gaps in the literature by conducting a home-based program designed to improve dual-task performance with a broader transfer-of-training effects in older adults. Participants will be randomly assigned to one of four groups (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chiang Mai
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Sripoom, Chiang Mai, Thailand, 50200
- Faculty of Associated Medical Sciences, Chiang Mai University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Able to walk at least 10 meters without any assistive device
- Having greater than 16/23 for illiterate persons, greater than 20/30 for primary education level persons, and greater than 23/30 for secondary education level persons on the Mini-Mental State Examination-Thai 2002 (MMSE-Thai2002)
Exclusion Criteria:
- Severe neurological problems that could account for possible imbalance such as cerebral vascular accident, Parkinson's disease, transient ischemic attacks, and neuropathy
- Severe musculoskeletal problems that could impact gait such as severe osteoarthritis and active inflammatory joint disease
- Severe cardiopulmonary problems such as asthma and chronic obstructive pulmonary disease
- Visual impairment that cannot be corrected by lenses
- Severe auditory impairment such as deafness
- Depression as scored ≥ 13 by Thai Geriatric Depression Scale (TGDS)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-task motor training group
The participants will receive only balance training which will progress from stance activities, to stance activities plus hand manipulation, then gait activities, and finally gait activities plus hand manipulation.
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Balance activities, using a task-oriented approach, progress participants from body stability, to body stability plus hand manipulation, then body transport, and finally body transport plus hand manipulation.
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|
Experimental: Single-task cognitive training group
The participants will receive cognitive training that will involve executive function, attention, and working memory.
|
Cognitive training involves executive function, attention, and working memory.
Examples of cognitive training include finding the exit to a maze, calculation, visual-spatial skills, Sudoku, Stroop color-word task, word search, spot the differences, visual discrimination, and memory scanning skills.
|
|
Experimental: Dual-task motor-cognitive training group
The participants assigned to the dual-task motor-cognitive training group will receive the same exercises as single-task motor training while simultaneously performing secondary tasks as those in the single-task cognitive training group.
|
Balance activities, using a task-oriented approach, progress participants from body stability, to body stability plus hand manipulation, then body transport, and finally body transport plus hand manipulation.
Cognitive training involves executive function, attention, and working memory.
Examples of cognitive training include finding the exit to a maze, calculation, visual-spatial skills, Sudoku, Stroop color-word task, word search, spot the differences, visual discrimination, and memory scanning skills.
|
|
Experimental: Dual-task cognitive-cognitive training group
The participants in the dual-task cognitive-cognitive trainings group will receive two cognitive tasks at the same time.
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The Dual-task cognitive-cognitive training involves applying two cognitive tasks at the same time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Center of Mass velocity and Base of Support distance
Time Frame: At baseline and after 4-week training
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The Center of Mass velocity and Base of Support distance is referred as the direction of the center of mass velocity in relation to base of support.
It is used to measure the control of dynamic balance throughout gait under single-task and dual-task conditions in order to examine training effect.
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At baseline and after 4-week training
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Spatio-temporal gait parameters
Time Frame: At baseline and after 4-week training
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Spatio-temporal gait parameters is measured throughout gait under single-task and dual-task conditions in order to examine training effect.
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At baseline and after 4-week training
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Collaborators and Investigators
Sponsor
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- The graduate school, CMU
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