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

NCT04545138 | Completed

• 1 other identifier: YM109069F
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cognitive Impairment

Keywords

Stroke; Cognitive Impairment; Cognitive and treadmill training

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Single walking performance- speed (cm/s)

  3 minutes

• Single walking performance-step length (cm)

  3 minutes

• Single walking performance-step time (s)

  3 minutes

• Single walking performance-cadence (steps/min)

  3 minutes

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

  3 minutes

Study Arms (2)

cognitive training during treadmill training group

EXPERIMENTAL

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 group

ACTIVE COMPARATOR

Treadmill training as an active control.

Other: Treadmill training

Interventions

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.

cognitive training during treadmill training group

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).

treadmill training group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, Beitou District, 112, Taiwan

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ray-Yau Wang, professor

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

• Yun-Hsien Liu

  National Yang Ming Chiao Tung University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: September 10, 2020
• Study Start: September 10, 2020
• Primary Completion: September 18, 2020
• Study Completion: November 22, 2021
• Last Updated: October 13, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)