Skip to main content
OpenTrials
Completed

NCT Number: NCT04545138

Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, Beitou District, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive training combine treadmill training

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

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).

Primary outcomes

  1. Trail-making test A&B

    Time frame: 8 minutes

    executive function (s)

  2. Stroop test

    Time frame: 10 minutes

    attention (number)

  3. Digit span test

    Time frame: 8 minutes

    memory (number)

  4. Clock drawing test

    Time frame: 10 minutes

    visuospatial function (score 1-10)

Secondary outcomes

  1. Single walking performance- speed (cm/s)

    Time frame: 3 minutes

    walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system

  2. Single walking performance-step length (cm)

    Time frame: 3 minutes

    step length in centimeters will be calculated during the single walking by using the GaitRite system

  3. Single walking performance-step time (s)

    Time frame: 3 minutes

    step time in seconds will be calculated during the single walking by using the GaitRite system

  4. Single walking performance-cadence (steps/min)

    Time frame: 3 minutes

    cadence in steps per minute will be calculated during the single walking by using the GaitRite system

  5. Cognitive dual task walking performance-speed (cm/s)

    Time frame: 3 minutes

    walking speed in centimeters per second will be calculated during the cognitive dual task walking by using the GaitRite system

  6. Cognitive dual task walking performance-step length (cm)

    Time frame: 3 minutes

    step length in centimeters will be calculated during the cognitive dual task walking by using the GaitRite system

  7. Cognitive dual task walking performance-step time (s)

    Time frame: 3 minutes

    step time in seconds will be calculated during the cognitive dual task walking by using the GaitRite system

  8. Cognitive dual task walking performance-cadence (steps/min)

    Time frame: 3 minutes

    cadence in steps per minute will be calculated during the cognitive dual task walking by using the GaitRite system

  9. Cognitive dual task walking performance-dual task cost (%)

    Time frame: 3 minutes

    dual task cost (%) will be calculated with the following formula: [(dual-task performance-single task performance) / single task performance] × 100%

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 10, 2020
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.