Comparative Efficacy of Two Different Dual-task Balance Interventions

NCT ID: NCT03234998

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-25
• Study Completion Date: 2019-02-25

Brief Summary

The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults.

Detailed Description

English Synopsis

I. Title of Study:

Comparative efficacy of two different dual-task balance interventions on balance, gait, and cognitive performance under single- and dual-task conditions in stroke patients and older adults

II. Study Objectives:

The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults. Specifically, the investigators will compare the immediate and retention effects of motor and cognitive dual-task balance training [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim 2). The third aim of this study is to elucidate the mechanisms underlying changes in balance, gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (Aim 3).

III. Study Design A prospective randomized control trial will be conducted at medical centers in this study. Fifty stroke patients and 48 elderly people will be randomly allocated to either MCDT or CDT group. Both groups will receive 12 hours of training over 4 weeks at progressively increasing task difficulty (60 minutes per session, three times a week, for four weeks). The CDT group will undertake dual-task balance training and concurrently perform only cognitive tasks with instruction of a variable priority. The MCDT group will train the same set of balance/gait activities as the CDT while simultaneously performing motor and cognitive tasks with instruction of a variable priority. During each session, all participants practice shifting attention between tasks by spending half of the training attention focus on the balance task, and half focus on the secondary cognitive or motor tasks. A blinded assessor will conduct three assessments at baseline, post intervention, and 1-month follow-up. At baseline, all participants will be examined balance, gait, and cognitive performance under single-task (standing, walking, cognitive tasks only) and dual-task conditions (standing/walking while performing cognitive tasks). Six cognitive tasks (simple reaction time task, serial three subtractions task, Stroop task, auditory Stroop task, spatial memory task, and choice reaction time task) will be used to examine dual-task performance because these tasks represent different domains of cognitive function (information processing speed, working memory, and executive function). The primary outcome measure of balance, gait, and cognition will be the sway index, gait speed, and composite score of accuracy and reaction time under single- and dual-task conditions. Secondary outcome measures will include: Berg Balance Scale, Timed Up and Go test under single- and dual-task conditions, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair Stand Test, and Patient Global Impression of Change. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between the groups.

Number of Planned Patients: 50 stroke patients and 48 elderly people Duration of the Study: 2017/08/01～2020/07/31

Conditions

Stroke; Healthy Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

motor-cognitive dual-task training

Participants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks.

Group Type: EXPERIMENTAL

motor-cognitive dual-task training

Intervention Type: DEVICE

Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.

cognitive dual-task training

Participants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks.

Group Type: ACTIVE_COMPARATOR

cognitive dual-task training

Intervention Type: DEVICE

Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.

Interventions

motor-cognitive dual-task training

Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.

Intervention Type: DEVICE

cognitive dual-task training

Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.

Intervention Type: DEVICE

Other Intervention Names

MCDT; CDT

Eligibility Criteria

Inclusion Criteria

• first-ever stroke with onset duration more than 3 months
• able to walk 10 m
• no severe vision, hearing, and language problems

• more than 65 years old
• able to walk 10 m
• no neurological or musculoskeletal diagnosis
• no severe vision, hearing, cognition, and language problems.

Exclusion Criteria

• orthopedic and other neurological disorders that affect walking
• other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
• moderate or severe cognitive impairments (score <21 on Mini-Mental State Examination)
• severe uncorrected visual deficits

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Li-Ling Chuang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Ling Chuang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Chang Gung University

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

1612190002

Identifier Type: -

Identifier Source: org_study_id