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StrokeNCT02686515

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

A study testing single-task balance training and dual-task balance training in people with Stroke, run by Chang Gung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke
What is being tested?
single-task balance training and dual-task balance training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTaiwan
Study dates
2 Mar 2016to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung University

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: Comparative Effectiveness Research of Dual-task and Single-task Balance Training on Cognitive-motor Interference, Balance Confidence, Fall Prevention, Functional Performance, and Quality of Life in People With Stroke

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).

Read the 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
Being tested
single-task balance training, dual-task balance training
Keywords
balance
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single-task balance trainingDevice

    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 trainingDevice

    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.

Study groups in NCT02686515
Study groupRoleWhat they receive
Single-task balance training groupActive comparatorParticipants 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.
Receives: Device: single-task balance training
Dual-task balance training groupExperimentalParticipants 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.
Receives: Device: dual-task balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 minutes

  2. 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.

    Measured: 5 minutes

  3. 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.

    Measured: 10 minutes

  4. 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.

    Measured: 30 minutes

Secondary outcomes (8)
  1. Berg Balance Scale (BBS)

    The BBS will be used to quantify balance performance under single-task conditions on tasks such as standing with eyes closed, standing with feet together, and picking up an object from the floor. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.

    Measured: 5-10 minutes

  2. Timed Up and Go test (TUG)

    The TUG test will be used as an index of mobility of the elderly and stroke patients.66 The TUG test measures the time it takes a participant to rise from a chair, walk 3 m, and then return to the chair and sit down. The TUG test will be administered under the single-task and dual-task conditions. In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG). The instruction for dual-TUG test is to walk with your comfortable speed and carry this tray in front of you with both hands without dropping glasses on the tray.

    Measured: 2 minutes

  3. Activity-specific balance confidence scale (ABC)

    The ABC will be used to determine self-reported confidence when performing 16 different daily activities, such as walking around the house, walking up and down stairs, and walking on slippery floors. A confidence rating scale ranges from 0% to 100%, with 0% indicating no confidence, and 100% indicating full confidence.

    Measured: 3 minutes

  4. Fugl-Meyer Assessment (FMA)

    The FMA motor subscale will be used to measure voluntary lower limb motor function in stroke participants with a 3-point ordinal scale on each item (0-cannot perform, 1-performs partially, 2-performs fully) (maximum: 34).

    Measured: 5 minutes

  5. Functional Independent Measurement (FIM)

    The FIM will be used to assess daily function. The level of participants' disability indicates the burden of caring for them and items are scored on the basis of how much assistance is required for participants to carry out activities of daily living. The FIM consists of 18 items grouped into 6 subscales: self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks.

    Measured: 5 minutes

  6. Nottingham Extended Activities of Daily Living Scale (NEADL)

    The NEADL was developed to assess the level of independence in instrumental activity of daily living of stroke patients after hospital discharge. It has four subscales (mobility, domestic, leisure and kitchen) and consists of 22 items scored on the basis of the requirement for help in performing the activity described. The subjects will be asked what they actually did but not what they could do to assess their real daily performance and their level of independence in daily life rather than their capabilities. Items will be scored from 0 to 3 points and summed to provide an overall score, with higher scores indicative of better activities participation.

    Measured: 5 minutes

  7. Stroke Impact Scale Version 3.0 (SIS 3.0)

    Health-related quality of life will be measured using the SIS 3.0, which is specific to the stroke population. The SIS 3.0 contains 59 items measuring 8 domains (i.e., strength, hand function, Activities of Daily Living/Instrumental Activities of Daily Living [ADL/IADL], mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.

    Measured: 10 minutes

  8. Fall rate

    Participants will be followed prospectively over a period of three months using a falls diary to document their falls event. To assure higher accuracy, participants will also receive monthly follow-up telephone calls to remind them to update their falls diary and the number of falls participants has been fallen in the previous month will be recorded. Participants will be categorized as multiple fallers (≧2 falls), single fallers (1 falls), and non-fallers (no falls) according to information from the falls diaries and monthly follow-up telephone calls.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2016 (estimated)
  2. Study start2 Mar 2016
  3. Primary completion26 May 2017
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686515
Sponsor's protocol ID
MOST104-2314-B-182-035-MY3
Status last verified
Feb 2024
First submitted
16 Feb 2016
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38885066

Questions about this trial

What is this clinical trial studying?

A study testing single-task balance training and dual-task balance training in people with Stroke, run by Chang Gung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sway index (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686515, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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