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

NCT02686515 | Completed DMC

• 1 other identifier: MOST104-2314-B-182-035-MY3
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

balance

Outcome Measures

Primary Outcomes (4)

• Sway index

  Participants will stand on a platform (Biosway Balance System, Biodex Medical Systems, Inc., NY, USA) and perform modified clinical test of sensory integration of balance test (mCTSIB) for 20 seconds in each of 4 conditions (Eyes open/closed, Firm/Foam surface). The instruction of this test is to maintain your center of balance and try not to move. The primary outcome of balance ability is sway index. The sway index is really the standard deviation of the sway angle. The higher the sway index the more unsteady the participant was during the test.

  10 minutes

• Gait speed

  Participants will walk 10m at their preferred speed and at fast speed. Participants will be instructed to begin walking about 1 m before stepping on the walkway and to keep walking about 1 m beyond the walkway to exclude acceleration and deceleration phases on the walkway. The time to complete the middle 10 m will be recorded using a stopwatch. The primary outcome measure will be gait speed under single- and dual-task conditions.

  5 minutes

• Composite score = Accuracy/Reaction time

  Participants will be asked to perform three different cognitive tasks while sitting, standing, walking at preferred speed, and walking at fast speed. The order of three cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions.These three cognitive tasks are simple reaction time task, counting backward by 3s, and Stroop task.To account for possible speed-accuracy trade-off, a composite score will be calculated by dividing accuracy (% correct responses) by verbal reaction time (milliseconds) will be used to indicate cognitive performance.

  10 minutes

• Cognitive-Motor Interference (CMI)

  The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate CMI for each of the balance/gait outcome measures and 3 cognitive measures using following formula: \[(Single-task - Dual-task)/Single-task \*100\]. Higher cost indicates poor performance on dual-task conditions.

  30 minutes

Secondary Outcomes (8)

• Berg Balance Scale (BBS)

  5-10 minutes

• Timed Up and Go test (TUG)

  2 minutes

• Activity-specific balance confidence scale (ABC)

  3 minutes

• Fugl-Meyer Assessment (FMA)

  5 minutes

• Functional Independent Measurement (FIM)

  5 minutes

Study Arms (2)

Single-task balance training group

ACTIVE COMPARATOR

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.

Device: single-task balance training

Dual-task balance training group

EXPERIMENTAL

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.

Device: dual-task balance training

Interventions

single-task balance training 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).

Single-task balance training group

dual-task balance training 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.

Dual-task balance training group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung University: lead
• Mackay Memorial Hospital: collaborator

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38885066 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li-Ling Chuang, Chuang

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 19, 2016
• Study Start: March 2, 2016
• Primary Completion: May 26, 2017
• Study Completion: July 31, 2019
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)