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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cognitive Impairment
• Intervention / Treatment: Other: cognitive training combine treadmill training; Other: Treadmill training

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitou District
    • Taipei, Beitou District, Taiwan, 112
      • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cognitive training during treadmill training group; Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously.	Other: cognitive training combine treadmill training; Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight), and ensures that patients can be cognitively trained at the same time. The cognitive training tasks will be projected on the screen and the participant have to answer the task orders during treadmill training simultaneously.
Active Comparator: treadmill training group; Treadmill training as an active control.	Other: Treadmill training; Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Ray-Yau Wang, professor, National Yang Ming University; Study Chair: Yun-Hsien Liu, National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): September 18, 2020
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Cognitive Impairment; Cognitive and treadmill training
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction
• Other Study ID Numbers: YM109069F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No