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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545138
• Other study ID #: YM109069F
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: November 22, 2021

Study information

• Verified date: July 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 22, 2021
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

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.
• 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).

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei	Beitou District

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trail-making test A&B	executive function (s)	8 minutes
Primary	Stroop test	attention (number)	10 minutes
Primary	Digit span test	memory (number)	8 minutes
Primary	Clock drawing test	visuospatial function (score 1-10)	10 minutes
Secondary	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
Secondary	Single walking performance-step length (cm)	step length in centimeters will be calculated during the single walking by using the GaitRite system	3 minutes
Secondary	Single walking performance-step time (s)	step time in seconds will be calculated during the single walking by using the GaitRite system	3 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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