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

NCT ID: NCT04545138

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2021-11-22

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.

Conditions

Stroke; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cognitive training during treadmill training group

Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously.

Group Type: EXPERIMENTAL

cognitive training combine treadmill training

Intervention Type: OTHER

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 group

Treadmill training as an active control.

Group Type: ACTIVE_COMPARATOR

Treadmill training

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ray-Yau Wang, professor

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Yun-Hsien Liu

Role: STUDY_CHAIR

National Yang Ming Chiao Tung University

Locations

National Yang-Ming University

Taipei, Beitou District, Taiwan

Countries

Taiwan

Other Identifiers

YM109069F

Identifier Type: -

Identifier Source: org_study_id