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StrokeNCT02270398

Dual-task Training in Chronic Stroke

A study testing Dual-task training group, Single-task training group and Flexibility and strength training group in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Stroke
What is being tested?
Dual-task training group, Single-task training group and Flexibility and strength training group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteHong Kong
Study dates
Oct 2014to Dec 2016
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of a stroke
  • more than 6 months of stroke onset
  • aged 50 years or above
  • community-dwelling
  • medically stable
  • score ≥21 on the Montreal Cognitive Assessment (MoCA)
Show all 9Show fewer
  • score ≤ 25 on the Mini Balance Evaluation Systems Test (Mini-BESTest)
  • able to ambulate without physical assistance of another person as determined during the 10-meter walk test
  • ability to follow 3-step commands

Who cannot join

  • having neurological conditions other than stroke
  • not community-dwelling prior to the stroke event
  • significant receptive and expressive aphasia
  • severe and uncorrected hearing or visual deficits
  • serious musculoskeletal disorders (e.g. amputation)
  • serious cardiovascular conditions affecting the ability to participate in exercise training
  • pain experienced at rest or movement
  • other serious illnesses that preclude participation

Trial locations and contacts

1 site in 1 country.

Echo Ouyang, BSc contact

27664844

echo.y.ouyang@polyu.edu.hk

Marco YC Pang, PhD contact

27667156

Marco.Pang@polyu.edu.hk

Hong Kong1 site, 1 recruiting
  • Hong Kong Polytechnic University

    Hung Hom

    Echo Ouyang, BSc, 85227664844, echo.y.ouyang@polyu.edu.hk

    Marco YC Pang, PhD, 85227667156, Marco.Pang@polyu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Training Dual-task Balance and Walking in Community-dwelling Older Adults With Chronic Stroke: a Randomized Controlled Trial

Background Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim The aim of this Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years.

Read more

There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.

Read the detailed description

Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years.

There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.

Study design

This will be a single-blinded randomized controlled trial (RCT). After baseline evaluation, subjects will be randomly allocated to one of the three groups: (1) dual-task training group, (2) single-task training group, (3) strengthening and flexibility exercise group (controls), using a 1:1:1 randomization sequence.

Measurements Outcomes will be used to compare the therapeutic effects of the 3 treatment groups. The outcome measurements (except data on incidence of falls) will take place at 3 time points: (1) within one week before initiation of intervention (baseline), (2) within one week after completion of training, (3) 8 weeks after completion of training. The fall data will be collected on a monthly basis until 6 months after termination of the intervention period. All assessments will be performed by a researcher who is blinded to group allocation.

Conditions
Stroke
Being tested
Dual-task training group, Single-task training group, Flexibility and strength training group
Keywords
Exercise, Balance, Gait, Community, Rehabilitation, Dual-task
Medical subject headings
Stroke, Motor Activity

What participants receive

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

  • Dual-task training groupBehavioural

    Balance and gait exercises while simultaneously engaging in a secondary cognitive task.

  • Single-task training groupBehavioural

    Balance/gait exercises and cognitive exercises done separately.

  • Flexibility and strength training groupBehavioural

    Whole-body flexibility exercises, upper limb strengthening exercises.

Study groups in NCT02270398
Study groupRoleWhat they receive
Dual-task training groupExperimentalParticipants in this group will receive dual-task balance and gait training for half hour and relaxation exercise for another half hour in each session. There will be 3 sessions per week for 8 weeks.
Receives: Behavioral: Dual-task training group
Single-task training groupActive comparatorThis group of subjects will participate in single-task gait and balance activities for half hour and single-task cognitive training in sitting position for another half hour in each session. There will be 3 sessions per week for 8 weeks.
Receives: Behavioral: Single-task training group
Flexibility and strength training groupActive comparatorThe subjects in this group will engage in flexibility exercises and upper limb strengthening exercises for one hour in each session. There will be 3 sessions per week for 8 weeks.
Receives: Behavioral: Flexibility and strength training group

What is being measured

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

  1. Timed-up-and-go test with and without dual-task

    A walking test

    Measured: week 0

  2. Timed-up-and-go test with and without dual-task

    A walking test

    Measured: week 8

  3. Timed-up-and-go test with and without dual-task

    A walking test

    Measured: week 16

Secondary outcomes (36)
  1. 10-meter walk test with and without dual-task

    A walking test

    Measured: week 0

  2. 10-meter walk test with and without dual-task

    A walking test

    Measured: week 8

  3. 10-meter walk test with and without dual-task

    A walking test

    Measured: week 16

  4. Sensory organization test with and without dual-task

    A standing balance test

    Measured: week 0

  5. Sensory organization test with and without dual-task

    A standing balance test

    Measured: week 8

  6. Sensory organization test with and without dual-task

    A standing balance test

    Measured: week 16

  7. Obstacle crossing with and without dual-task

    A walking test

    Measured: week 0

  8. Obstacle crossing with and without dual-task

    A walking test

    Measured: week 8

  9. Obstacle crossing with and without dual-task

    A walking test

    Measured: week 16

  10. Mini-Balance Evaluations Systems Test

    A balance test

    Measured: week 0

  11. Mini-Balance Evaluations Systems Test

    A balance test

    Measured: week 8

  12. Mini-Balance Evaluations Systems Test

    A balance test

    Measured: week 16

  13. Activities-specific balance confidence scale

    A questionnaire

    Measured: week 0

  14. Activities-specific balance confidence scale

    A questionnaire

    Measured: week 8

  15. Activities-specific balance confidence scale

    A questionnaire

    Measured: week 16

  16. Stroke Specific Quality of Life Scale

    A questionnaire

    Measured: week 0

  17. Stroke Specific Quality of Life Scale

    A questionnaire

    Measured: week 8

  18. Stroke Specific Quality of Life Scale

    A questionnaire

    Measured: week 16

  19. Motricity Index

    A muscle strength test

    Measured: week 0

  20. Motricity Index

    A muscle strength test

    Measured: week 8

  21. Motricity Index

    A muscle strength test

    Measured: week 16

  22. Chedoke Arm and Hand Activity Inventory

    An arm function test

    Measured: week 0

  23. Chedoke Arm and Hand Activity Inventory

    An arm function test

    Measured: week 8

  24. Chedoke Arm and Hand Activity Inventory

    An arm function test

    Measured: week 16

  25. Frenchay Activities Index

    A questionnaire

    Measured: week 0

  26. Frenchay Activities Index

    A questionnaire

    Measured: week 8

  27. Frenchay Activities Index

    A questionnaire

    Measured: week 16

  28. Tinetti Assessment Tool (Gait)

    A walking test

    Measured: week 0

  29. Tinetti Assessment Tool (Gait)

    A walking test

    Measured: week 8

  30. Tinetti Assessment Tool (Gait)

    A walking test

    Measured: week 16

  31. Incidence of fall

    fall follow-up using log book and monthly telephone calls

    Measured: week 0-6 months after training

  32. Global Rating of Change score

    A questionnaire

    Measured: week 8

  33. Global Rating of Change score

    A questionnaire

    Measured: week 16

  34. Upper limb muscle strength

    dynamometry test

    Measured: week 0

  35. Upper limb muscle strength

    dynamometry test

    Measured: week 8

  36. Upper limb muscle strength

    dynamometry test

    Measured: week 16

Timeline

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

  1. First posted21 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2016 (estimated)
  4. Study completionDec 2016 (estimated)

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
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270398
Sponsor's protocol ID
HSEARS20140714003-01
Status last verified
Nov 2014
First submitted
17 Oct 2014
Last updated
11 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Said CM, Galea MP, Lythgo N. People with stroke who fail an obstacle crossing task have a higher incidence of falls and utilize different gait patterns compared with people who pass the task. Phys Ther. 2013 Mar;93(3):334-44. doi: 10.2522/ptj.20120200. Epub 2012 Oct 11.

    PubMed 23064734
  • Cockburn J, Haggard P, Cock J, Fordham C. Changing patterns of cognitive-motor interference (CMI) over time during recovery from stroke. Clin Rehabil. 2003 Mar;17(2):167-73. doi: 10.1191/0269215503cr597oa.

    PubMed 12625657
  • Silsupadol P, Lugade V, Shumway-Cook A, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Training-related changes in dual-task walking performance of elderly persons with balance impairment: a double-blind, randomized controlled trial. Gait Posture. 2009 Jun;29(4):634-9. doi: 10.1016/j.gaitpost.2009.01.006. Epub 2009 Feb 7.

    PubMed 19201610
  • Pichierri G, Wolf P, Murer K, de Bruin ED. Cognitive and cognitive-motor interventions affecting physical functioning: a systematic review. BMC Geriatr. 2011 Jun 8;11:29. doi: 10.1186/1471-2318-11-29.

    PubMed 21651800
  • Yang YR, Wang RY, Chen YC, Kao MJ. Dual-task exercise improves walking ability in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 Oct;88(10):1236-40. doi: 10.1016/j.apmr.2007.06.762.

    PubMed 17908563
  • Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.

    PubMed 30571419

Questions about this trial

What is this clinical trial studying?

A study testing Dual-task training group, Single-task training group and Flexibility and strength training group in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Nov 2014. 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 Hong Kong. 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?

Results are not available in the source record.

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

Contact Echo Ouyang, BSc (27664844, echo.y.ouyang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed-up-and-go test with and without dual-task (time frame: week 0). The study lists 3 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 NCT02270398, which also lists 6 linked publications.

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 11 Nov 2014.

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Dual-task Training in Chronic Stroke (NCT02270398) | AzTrials