Comparative Effectiveness Research of Dual-task and Single-task Balance Training in People With Stroke

NCT ID: NCT02686515

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2019-07-31

Brief Summary

The objective of this study is to investigate the effect of dual-task training at impairment, disability, and participation levels for stroke survivors and investigate possible factors affecting cognitive-motor interference (CMI) under dual-task conditions. Specifically, we will compare the immediate and retention effects of dual-task balance training and single-task balance training on CMI, balance confidence, fall rate, functional performance, and quality of life in individuals with stroke (Aim 1). The second aim of this study is to explore how lateralization, stroke chronicity, task type, and task difficulty may influence patterns of CMI (Aim 2). The third aim of this study is to investigate whether dual-task balance assessments are more sensitive than single-balance assessment in distinguishing stroke fallers from stroke non-fallers (Aim 3).

Detailed Description

Gait-related dual-task impairments are common problems experienced in people with stroke by walking more slowly or taking shorter steps in dual-task walking. Decrements in dual-task capacity may predispose stroke survivors to risk of falls and affect negatively on functional independence and quality of life. Currently there is a need to explore whether people with stroke practice dual-tasking in standing and walking will lead to enhance dual-task performance and reduce falls rate. However, there is a lack of prospective, controlled studies which quantify balance, gait, cognition, and fall-risk after dual-task training. The objective of this study is to investigate the effect of dual-task training at impairment, disability, and participation levels for stroke survivors and investigate possible factors affecting cognitive-motor interference (CMI) under dual-task conditions. Specifically, we will compare the immediate and retention effects of dual-task balance training and single-task balance training on CMI, balance confidence, fall rate, functional performance, and quality of life in individuals with stroke (Aim 1). The second aim of this study is to explore how lateralization, stroke chronicity, task type, and task difficulty may influence patterns of CMI (Aim 2). The third aim of this study is to investigate whether dual-task balance assessments are more sensitive than single-balance assessment in distinguishing stroke fallers from stroke non-fallers (Aim 3).

A prospective randomized control trial will be conducted at 2 medical centers in this study. Forty-eight people with stroke will be randomly allocated to either a single- or dual-task balance training 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 single-task training group will undertake balance training and gait training. The dual-task training group will train the same set of balance activities as the single-task training while simultaneously performing a variety of added cognitive or motor tasks with instruction of a variable priority. During each session, participants in dual-task training 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 task. A blinded assessor will conduct three assessments at baseline, post intervention, and 1-month follow-up. At baseline, all participants will be examine balance, gait, and cognitive performance under single-task (standing/walking at preferred speed and fast speed only, cognitive task only) and dual-task conditions (standing/walking at preferred speed and fast speed and concurrent cognitive task). Three cognitive tasks (simple auditory reaction time task, counting backward by 3s task, and Stroop task) will be used to examine patterns of CMI because these tasks represent different domains of cognitive function (information processing speed, working memory, and executive function). The primary outcome measure of cognition will be the composite score of accuracy and reaction time. The primary outcome measure of balance will be the sway index in mCTSIB test on a BioSway balance system under single- and dual-task standing. The primary outcome measure of gait will be gait speed on 10 m walk test under single- and dual-task walking. Secondary outcome measures will include: Berg Balance Scale, the Timed Up and Go test under single- and dual-task conditions, Activity-specific Balance Confidence Scale, Fugl-Meyer Assessment, Functional Independence Measure, Nottingham Extended Activities of Daily Living Scale, and Stroke Impact Scale. Additionally, falls will be prospectively monitored monthly and recorded during the following 6 months after the training. Repeated measure ANOVA will be used to compare measurements baseline, after training, and follow-up between the groups.

Conditions

Stroke

Study Design

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

Study Groups

Single-task balance training group

Participants in the single-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks. They will start walking on a treadmill with a self-selected comfortable speed for 5 minutes of warm-up and then receive an individually-progressed program of balance training aimed at improving standing balance and walking abilities.

Group Type: ACTIVE_COMPARATOR

single-task balance training

Intervention Type: DEVICE

The framework of progressive balance exercises in the single-task training will include body stability tasks (Stance activities), transitional activities (Sit to stand and walk), and body transfer tasks (Gait activities). These exercises target various systems for balance control, such as stability limits (standing with changes in base of support and weight shifting), sensory orientation (standing on compliant surfaces with eyes open and eyes closed), postural responses (reactions to balance perturbation, sit to stand and walk), and gait (treadmill walking with increasing speed).

Dual-task balance training group

Participants in the 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. They will perform a cognitive task or motor task concurrently with the balance/gait task. The framework of progressive balance exercises in the dual-task training group will be progressed from simple to more complex tasks as outlined for the single-task training group. In addition, a variety of added tasks will be progressively integrated into the dual-task balance training program.

Group Type: EXPERIMENTAL

dual-task balance training

Intervention Type: DEVICE

Three cognitive tasks will be used for dual-task training while standing and walking: auditory discrimination tasks, verbal fluency tasks, and calculation tasks. In addition, motor tasks such as carrying a bag, holding a glass of water, alternating hand movement, carrying a tray with glasses, or getting keys out of a pocket will also be included as added tasks.

Interventions

single-task balance training

The framework of progressive balance exercises in the single-task training will include body stability tasks (Stance activities), transitional activities (Sit to stand and walk), and body transfer tasks (Gait activities). These exercises target various systems for balance control, such as stability limits (standing with changes in base of support and weight shifting), sensory orientation (standing on compliant surfaces with eyes open and eyes closed), postural responses (reactions to balance perturbation, sit to stand and walk), and gait (treadmill walking with increasing speed).

Intervention Type: DEVICE

dual-task balance training

Three cognitive tasks will be used for dual-task training while standing and walking: auditory discrimination tasks, verbal fluency tasks, and calculation tasks. In addition, motor tasks such as carrying a bag, holding a glass of water, alternating hand movement, carrying a tray with glasses, or getting keys out of a pocket will also be included as added tasks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• first-ever stroke with onset duration more than 3 months
• able to walk with or without walking aids
• self-selected gait speed at least 0.6 m per second determined during a 10m walk test
• no severe vision, hearing, and language problems
• have experienced at least one fall in the previous year

Exclusion Criteria

• have orthopedic condition affecting their gait or other diseases that might interfere with participation in the training program
• could not stand for at least two minutes without assistance
• score less than 24 on the Mini-Mental State Examination

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: collaborator

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Li-Ling Chuang

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Ling Chuang, Chuang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Chang Gung University

Taoyuan District, , Taiwan

Countries

Taiwan

References

Chuang LL, Hsu AL, Lin YH, Yu MH, Hu GC, Ou YC, Wong AM. Multimodal training with dual-task enhances immediate and retained effects on dual-task effects of gait speed not by cognitive-motor trade-offs in stroke survivors: a randomized controlled trial. Disabil Rehabil. 2025 Mar;47(5):1194-1203. doi: 10.1080/09638288.2024.2365986. Epub 2024 Jun 17.

Reference Type: DERIVED

PMID: 38885066 (View on PubMed)

Other Identifiers

MOST104-2314-B-182-035-MY3

Identifier Type: -

Identifier Source: org_study_id