NCT02753322

Brief Summary

Stroke is one of the most common chronic disabling conditions in Hong Kong. People after stroke may suffer from certain degree of physical impairment and disability. Resuming safe ambulation in the community appears to be a big challenge to them as it always involves the simultaneous performance of two or more tasks (dual task) such as walking and talking with someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that the interference from dual tasks (dual task interference) may significantly impact the recovery of the functional walking. To date, the relevance of dual task walking to daily community is widely documented and the ability of managing dual task is therefore particularly important. Evidences supported that dual task training showed its promising effect on the balance and walking performance amongst people with neurological disorders, such as chronic stroke. In light of this, the introduction of dual task based balance and walking training into physiotherapy program for stroke patient may enhance the balance and walking performance and hence promote successful community ambulation. Yet, there is limited evidence on its effect in sub-acute stroke. Objective: To examine the effectiveness of a dual-task based balance and walking training program on performance and dual task interference in balance and walking ability, balance self-efficacy and incidence of falls in people with sub-acute 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 Apr 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

April 24, 2016

Last Update Submit

April 26, 2016

Conditions

Keywords

Dual task trainingDual task interferenceSub-acute strokePhysiotherapy trainingCommunity ambulationBalance

Outcome Measures

Primary Outcomes (1)

  • Degree of the dual-task interference

    It will be assessed by calculating the percentage of the difference between single task performance (2 walking tasks and 2 balance tasks) and dual task performance of the 2 walking tasks and 2 balance tasks while engaging in 3 attention demanding tasks.

    Baseline, 8 weeks, 16 weeks

Secondary Outcomes (7)

  • Standing balance with eyes opened in dual task conditions

    Baseline, 8 weeks, 16 weeks

  • Standing balance with eyes closed in dual task conditions

    Baseline, 8 weeks, 16 weeks

  • 10 metre walk test in dual task conditions

    Baseline, 8 weeks, 16 weeks

  • Obstacle crossing test in dual task conditions

    Baseline, 8 weeks, 16 weeks

  • Chinese version of Activities-specific Balance Confidence (ABC) Scale

    Baseline, 8 weeks, 16 weeks

  • +2 more secondary outcomes

Study Arms (3)

Dual-task training group

EXPERIMENTAL

Subjects in this group will have 30 minutes of dual-task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises. The training program will last for 8 weeks with frequency of 2 sessions a week.

Other: Dual task training

Single-task training group

ACTIVE COMPARATOR

Subjects in this group will have single-task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately. The training program will last for 8 weeks with frequency of 2 sessions a week.

Other: Single-task training

Limbs exercise group

ACTIVE COMPARATOR

Subjects in this group will have stretching and strengthening exercise for 60 minutes. The training program will last for 8 weeks with frequency of 2 sessions a week.

Other: Limbs exercise

Interventions

Balance and walking exercises with simultaneously engaging in attention demanding tasks

Dual-task training group

Balance and walking exercises and and attention demanding task performed separately

Single-task training group

Stretching and strengthening exercises

Limbs exercise group

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a stroke confirmed by the individual's physician, between 1 month and 6 months post-stroke onset
  • Aged ≥50
  • Community-dwelling prior to stroke onset (defined as living in one's own home or the home of a relative, friend or caregiver)
  • Medically stable
  • Montreal Cognitive Assessment (MoCA) scored ≥21
  • Ability to follow 3-step commands
  • Having motor impairment in the affected lower extremity \[Chedoke McMaster Stroke Assessment (CMSA) leg and foot summative score of 4-13 out of 14)\], and upper extremity (CMSA arm and hand summative score of 4-13 out of 14)
  • Having balance deficits (Mini-Balance Evaluation Systems test score \<24)
  • Able to ambulate without physical assistance of another person as determined during the 10-meter walk test

You may not qualify if:

  • Recurrent stroke
  • Having neurological conditions other than stroke
  • significant receptive and expressive aphasia
  • Severe and uncorrected hearing or visual deficits
  • Serious musculoskeletal (e.g. amputation) or cardiovascular conditions affecting the ability to exercise (e.g. congestive heart failure), pain experienced at rest or movement, and other serious illnesses that preclude participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Margaret WY POON, MSc

    The Queen Elizabeth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret WY POON, MSc

CONTACT

Sally PC WAN, MSc

CONTACT

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
Senior Physiotherapist

Study Record Dates

First Submitted

April 24, 2016

First Posted

April 27, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

April 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations