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Clinical Trials/NCT04545138
NCT04545138
Completed
Not Applicable

Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment

National Yang Ming Chiao Tung University1 site in 1 country8 target enrollmentSeptember 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
National Yang Ming Chiao Tung University
Enrollment
8
Locations
1
Primary Endpoint
Clock drawing test
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Post-stroke cognitive impairment is common in stroke survivors. Cognitive function is related to walking ability. The dual task walking is required for daily activities, however, such ability is even more challenging than single walking for people with stroke. The purpose of present study is to investigate the effects of combining cognitive and treadmill training on cognitive function and dual task walking performance in chronic stroke patients with cognitive impairment.

Detailed Description

This is a single-blinded, randomized controlled trial with pre- and post-measurements. 24 subjects will be recruited, and randomly assigned to one of two groups: cognitive training during treadmill training group (experimental group) and treadmill training group (control group). The intervention for both group will be 30 minutes per session, 3 sessions per week for a total of 4 weeks. Statistical data analysis will use the SPSS 25.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to compare between time and groups. The significant level is set at 0.05.

Registry
clinicaltrials.gov
Start Date
September 10, 2020
End Date
November 22, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age over 50 years old
  • chronic stroke (onset \>6 months)
  • with mini-mental state examination (MMSE) score≧24
  • Montreal cognitive assessment (MoCA) score\<26 (impaired cognition)
  • ability to walk independently for at least 10 meters without assistive devices or support
  • ability to read and write cognitive tests

Exclusion Criteria

  • diagnosis of dementia
  • unstable physical condition
  • any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study
  • visual or auditory disturbances

Outcomes

Primary Outcomes

Clock drawing test

Time Frame: 10 minutes

visuospatial function (score 1-10)

Trail-making test A&B

Time Frame: 8 minutes

executive function (s)

Digit span test

Time Frame: 8 minutes

memory (number)

Stroop test

Time Frame: 10 minutes

attention (number)

Secondary Outcomes

  • Single walking performance- speed (cm/s)(3 minutes)
  • Single walking performance-step time (s)(3 minutes)
  • Cognitive dual task walking performance-cadence (steps/min)(3 minutes)
  • Single walking performance-step length (cm)(3 minutes)
  • Single walking performance-cadence (steps/min)(3 minutes)
  • Cognitive dual task walking performance-speed (cm/s)(3 minutes)
  • Cognitive dual task walking performance-step length (cm)(3 minutes)
  • Cognitive dual task walking performance-dual task cost (%)(3 minutes)
  • Cognitive dual task walking performance-step time (s)(3 minutes)

Study Sites (1)

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