Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment

Not Applicable

Completed

• Conditions: Stroke; Cognitive Impairment
• Interventions: Other: cognitive training combine treadmill training; Other: Treadmill training

• Registration Number: NCT04545138
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-09-07
• Study Start: 2020-09-10
• Study First Posted: 2020-09-10
• Primary Completion: 2020-09-18
• Study Completion: 2021-11-22
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive training during treadmill training group	cognitive training combine treadmill training	Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously.
treadmill training group	Treadmill training	Treadmill training as an active control.

Primary Outcome Measures

Name	Time	Method
Clock drawing test	10 minutes	visuospatial function (score 1-10)
Trail-making test A&B	8 minutes	executive function (s)
Digit span test	8 minutes	memory (number)
Stroop test	10 minutes	attention (number)

Secondary Outcome Measures

Name	Time	Method
Single walking performance- speed (cm/s)	3 minutes	walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system
Single walking performance-step time (s)	3 minutes	step time in seconds will be calculated during the single walking by using the GaitRite system
Cognitive dual task walking performance-cadence (steps/min)	3 minutes	cadence in steps per minute will be calculated during the cognitive dual task walking by using the GaitRite system
Single walking performance-step length (cm)	3 minutes	step length in centimeters will be calculated during the single walking by using the GaitRite system
Single walking performance-cadence (steps/min)	3 minutes	cadence in steps per minute will be calculated during the single walking by using the GaitRite system
Cognitive dual task walking performance-speed (cm/s)	3 minutes	walking speed in centimeters per second will be calculated during the cognitive dual task walking by using the GaitRite system
Cognitive dual task walking performance-step length (cm)	3 minutes	step length in centimeters will be calculated during the cognitive dual task walking by using the GaitRite system
Cognitive dual task walking performance-dual task cost (%)	3 minutes	dual task cost (%) will be calculated with the following formula: \[(dual-task performance-single task performance) / single task performance\] × 100%
Cognitive dual task walking performance-step time (s)	3 minutes	step time in seconds will be calculated during the cognitive dual task walking by using the GaitRite system

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Beitou District, Taiwan