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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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