NCT02270398

Brief 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

October 17, 2014

Last Update Submit

November 9, 2014

Conditions

Stroke

Keywords

ExerciseBalanceGaitCommunityRehabilitationDual-task

Outcome Measures

Primary Outcomes (3)

  • Timed-up-and-go test with and without dual-task

    A walking test

    week 0

  • Timed-up-and-go test with and without dual-task

    A walking test

    week 8

  • Timed-up-and-go test with and without dual-task

    A walking test

    week 16

Secondary Outcomes (36)

  • 10-meter walk test with and without dual-task

    week 0

  • 10-meter walk test with and without dual-task

    week 8

  • 10-meter walk test with and without dual-task

    week 16

  • Sensory organization test with and without dual-task

    week 0

  • Sensory organization test with and without dual-task

    week 8

  • +31 more secondary outcomes

Study Arms (3)

Dual-task training group

EXPERIMENTAL

Participants 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.

Behavioral: Dual-task training group

Single-task training group

ACTIVE COMPARATOR

This 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.

Behavioral: Single-task training group

Flexibility and strength training group

ACTIVE COMPARATOR

The 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.

Behavioral: Flexibility and strength training group

Interventions

Dual-task training groupBEHAVIORAL

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

Dual-task training group
Single-task training groupBEHAVIORAL

Balance/gait exercises and cognitive exercises done separately.

Single-task training group
Flexibility and strength training groupBEHAVIORAL

Whole-body flexibility exercises, upper limb strengthening exercises.

Flexibility and strength training group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hung Hom, Hong Kong

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23064734BACKGROUND

  • 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.

    PMID: 12625657BACKGROUND

  • 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.

    PMID: 19201610BACKGROUND

  • 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.

    PMID: 21651800BACKGROUND

  • 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.

    PMID: 17908563BACKGROUND

  • 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.

    PMID: 30571419DERIVED

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Pliability

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Marco YC Pang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Echo Ouyang, BSc

CONTACT

27664844echo.y.ouyang@polyu.edu.hk

Marco YC Pang, PhD

CONTACT

27667156Marco.Pang@polyu.edu.hk

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
Professor

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

HK(1)