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Clinical Trials/NCT06392945
NCT06392945
Recruiting
Not Applicable

Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training on Community Walking Capacity, Walking Automaticity, and Social Participation in Individuals With Chronic Stroke: a Randomized Controlled Trial

Chang Gung University1 site in 1 country90 target enrollmentMay 24, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Chang Gung University
Enrollment
90
Locations
1
Primary Endpoint
swing phase asymmetry under single-task walking and dual-task walking with the Stroop task
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The first objective of this study is to examine the superiority of the combined rhythmic auditory cueing with cognitive treadmill training (combined group) in people with stroke as compared with the cognitive treadmill walking training (cognitive group) or treadmill walking training alone (treadmill group) (Aim 1). The study's second aim is to investigate the factors affecting the improvement in community walking capacity after interventions and to explore whether changes in community walking capacity are associated with changes in participation after interventions (Aim 2).

Detailed Description

A single-blind, randomized controlled trial is conducted at medical centers. Ninety stroke patients will be randomized to one of the three groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). The cognitive group will receive cognitive training while walking at a progressive speed on the treadmill. The treadmill-alone group will train only in treadmill walking with progressive speed adjusted weekly. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures are gait and cognition under single- and dual-task conditions. The secondary outcome measures are the 6-minute Walk Test, Mini-BESTest, Stroke Impact Scale, and Walking Ability Questionnaire.

Registry
clinicaltrials.gov
Start Date
May 24, 2024
End Date
July 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Li-Ling Chuang

Associated Professor

Chang Gung University

Eligibility Criteria

Inclusion Criteria

  • diagnosed with first-time stroke;
  • more than 6 months after stroke onset;
  • able to walk 10 meters;
  • no severe vision, hearing, or speech impairments;
  • understand and follow the instructions and sign the Informed Consent Form;
  • older than 20 years old.

Exclusion Criteria

  • orthopedic problems affecting walking or other diseases that may interfere with study participation;
  • a score of less than 24 on the mini-mental state examination (MMSE);
  • severe balance disorder with a total score of less than 45 points Berg Balance Scale.

Outcomes

Primary Outcomes

swing phase asymmetry under single-task walking and dual-task walking with the Stroop task

Time Frame: baseline, after 4-week intervention, one-month follow-up

Swing phase asymmetry (%) is the ratio of swing which compares the time in the air for the two feet, in percent.

stride length asymmetry under single-task walking and dual-task walking with the Stroop task

Time Frame: baseline, after 4-week intervention, one-month follow-up

Stride length asymmetry (%) is the ratio of stride length which compares the stride length for the two feet, in percent. A perfect symmetry outputs a value of 0%.

walking speed (m/s) under single-task walking and dual-task walking with the Stroop task

Time Frame: baseline, after 4-week intervention, one-month follow-up

Participants will walk 10 meters at their preferred speed with and without the Stroop task twice, respectively. The spatiotemporal gait parameters will be examined using Physilog® sensors (Gait Up, Switzerland) and analyzed by the Gait Analysis Package software on the USB key. Walking speed (m/s) is the mean speed of forward walking, calculated in meters per second.

cognitive composite score

Time Frame: baseline, after 4-week intervention, one-month follow-up

The Stroop task is the commonly utilized dual-task paradigm and measures executive function and response inhibition, which plays a vital role during walking. Therefore, the Stroop task will be selected to assess cognitive dual-task walking. The Stroop task will be performed while sitting and walking to assess executive function under single-task and dual-task conditions. The following is the formula for calculating the cognitive composite score: Cognitive composite score of the Stroop task = \[Accuracy(%)/Reaction time(milliseconds)\] \* 100. The better the cognitive performance of the Stroop task, the higher the cognitive composite score. The instructions for the dual-task walking (walking + Stroop) are designed to encourage neutral prioritization between the two tasks ("walk at the preferred speed while performing the Stroop task as accurately and quickly as you can").

Secondary Outcomes

  • Automaticity(baseline, after 4-week intervention, one-month follow-up)
  • Mini-Balance Evaluation System Test, Mini-BESTest(baseline, after 4-week intervention, one-month follow-up)
  • Task-specific dual-task interference(baseline, after 4-week intervention, one-month follow-up)
  • 6-minute Walking test, 6MWT(baseline, after 4-week intervention, one-month follow-up)
  • Walking ability questionnaire(baseline, after 4-week intervention, one-month follow-up)
  • Stroke impact scale, SIS(baseline, after 4-week intervention, one-month follow-up)

Study Sites (1)

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