Cognitive-motor Training in Parkinson Disease

June 11, 2025 updated by: Yea-Ru Yang, National Yang Ming Chiao Tung University

Cognitive-motor Training on Brain Activity, Cognitive Function, and Walking Ability in People With Parkinson Disease

Literature reviews showed the cognitive-motor training that combines cognitive tasks may enhance cognitive functions more effectively than individual interventions. Stepping-based cognitive-motor training has been shown to improve cognitive functions, balance, and gait performance in older adults. However, there is insufficient research evidence on the impact and correlation of this training mode on the walking ability, executive functions, and brain activity changes in people with PD. Therefore, this study is designed to investigate the effects of stepping-based cognitive-motor training on the walking ability, executive functions, and brain activity in people with PD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • National Yang Ming Chiao Tung University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnoses of idiopathic Parkinson disease
  • Stable dopaminergic medicine ≥ 2 weeks
  • Able to walk 10 meters without aid
  • Mini-Mental Status Examination ≥ 24 points
  • No uncorrected visual or auditory disorders
  • Education at least junior high school
  • No other disease may affect balance

Exclusion Criteria:

  • Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
  • History of brain surgery (e.g. deep brain stimulation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive-motor training group
Participants receive 16 sessions of cognitive-motor training.
Other: Cognitive-motor training
Cognitive-motor training is that cognitive tasks incorporated into motor tasks.
Active Comparator: Control group
Participants receive 16 sessions of conventional physiotherapy.
Other: Conventional physiotherapy
Conventional physiotherapy includes stretching, ROM exercise, strengthening exercise, and eye-hand coordination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait variability
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean * 100%
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Gait speed
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Using GAITRite system to measure gait speed
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Step length
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Using GAITRite system to measure step length
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Step width
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Using GAITRite system to measure step width
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Single support time
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Using GAITRite system to measure single support time
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Double support time
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Using GAITRite system to measure double support time
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Frontal Assessment Battery
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
The score ranged from 0 to 18. Higher scores show better executive function.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Stroop color and word test
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Record numbers of corrected color words which the subject responds within 45 sec.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Digit span test
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Digit span test contain forward and backward part. Scores of forward digit span ranges from 0 to 16. Score of backward digit span ranges from 0 to 14. Higher scores indicate better executive function.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Event-related potential - N2
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Measure event-related potential through electroencephalography under single-task and dual-task paradigm.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Event-related potential - P300
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Measure event-related potential through electroencephalography under single-task and dual-task paradigm.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Go/Nogo test
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Behavioral test during measuring electroencephalography.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Trail making test
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Trail making test contain part A and part B. Faster completing the test indicates better executive function.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Balance Evaluation Systems Test
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Mini-Balance Evaluation Systems Test scores range from 0 to 28. Higher scores indicate better balance ability.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Montreal Cognitive Assessment
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Montreal Cognitive Assessment ranges from 0 to 30. Higher scores reflect better cognitive performances.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Timed up and go test
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Record time of performing timed up and go test
Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Parkinson Disease Questionnaire
Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Parkinson Disease Questionnaire assess quality of life in people with Parkinson disease. Lower scores reflect higher quality of life.
Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming Chiao Tung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYCU113006AF2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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