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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02280928
Other study ID # The graduate school, CMU
Secondary ID
Status Completed
Phase N/A
First received October 30, 2014
Last updated July 21, 2015
Start date October 2014
Est. completion date July 2015

Study information

Verified date July 2015
Source Chiang Mai University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethics committee, Faculty of Associated Medical Sciences, Chiang Mai university
Study type Interventional

Clinical Trial Summary

The purpose of this study is to (1) develop and test the effectiveness of home-based interventions on dual-task performance in older adults; and (2) determine the generalizability of the four trainings (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings) to novel tasks.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Balance exercise
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
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.
Dual-task cognitive-cognitive training
The Dual-task cognitive-cognitive training involves applying two cognitive tasks at the same time.

Locations

Country Name City State
Thailand Faculty of Associated Medical Sciences, Chiang Mai University Sripoom Chiang Mai

Sponsors (1)

Lead Sponsor Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Center of Mass velocity and Base of Support distance 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. At baseline and after 4-week training Yes
Primary Spatio-temporal gait parameters Spatio-temporal gait parameters is measured throughout gait under single-task and dual-task conditions in order to examine training effect. At baseline and after 4-week training Yes
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