NCT04328779

Brief Summary

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with the Stroop task for chronic stroke individuals (Aim 1). The second aim of this study is to compare the effects of multi-task walking training mode to traditional rehabilitation in patients with chronic stroke (Aim 2). The third aim of this study is to compare the immediate, retained, and transfer effect of multi-task overground walking training to multi-task treadmill walking training on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke (Aim 3).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

March 30, 2020

Last Update Submit

February 5, 2024

Conditions

Keywords

multi-task trainingcommunity ambulationcognition

Outcome Measures

Primary Outcomes (2)

  • gait speed

    Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch or Physilog® sensors (Gait Up, Switzerland). The primary gait parameter is gait speed (cm/s) under single-task and dual-task walking conditions using the 10 Meter Walking Test.

    5 minutes

  • composite score

    For the Stroop task, we will calculate the composite score for the Stroop task under single-task and dual-task walking conditions by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs.

    5 minutes

Secondary Outcomes (8)

  • Mini-Balance Evaluation Systems Test (Mini-BESTest)

    10 minutes

  • Timed Up and Go Test (TUG)

    2 minutes

  • Functional Gait Assessment (FGA)

    10 minutes

  • Berg Balance Scale (BBS)

    5-10 minutes

  • 6-minute Walk Test

    6 minutes

  • +3 more secondary outcomes

Study Arms (3)

multi-task overground walking training

EXPERIMENTAL

The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks.

Other: The multi-task overground walking training

multi-task treadmill walking

ACTIVE COMPARATOR

The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill.

Device: The multi-task treadmill walking training

traditional rehabilitation

ACTIVE COMPARATOR

Traditional rehabilitation group will train strength, balance, and gait.

Other: Traditional rehabilitation

Interventions

The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks for 30 minutes per session, 3 times a week for 4 weeks.

multi-task overground walking training

The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill for 30 minutes per session, 3 times a week for 4 weeks.

multi-task treadmill walking

Traditional rehabilitation will train strength, balance, and gait for 30 minutes per session, 3 times a week for 4 weeks.

traditional rehabilitation

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first-ever stroke with onset duration more than 3 months
  • able to walk 10 m
  • no severe vision, hearing, and language problems.

You may not qualify if:

  • orthopedic and other neurological disorders that affect walking
  • other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
  • moderate or severe cognitive impairments (score \< 24 on Mini-Mental State Examination)
  • severe uncorrected visual deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memory Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Li-Ling Chuang, Ph.D.

    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

March 30, 2020

First Posted

March 31, 2020

Study Start

August 14, 2020

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations