Parkinson DiseaseNCT06588439
Cognitive-motor Training in Parkinson Disease
A study testing Cognitive-motor training and Conventional physiotherapy in people with Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cognitive-motor training and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
- History of brain surgery (e.g. deep brain stimulation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei, 112
Yea-Ru Yang, PhD, yryang@nycu.edu.tw
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Cognitive-motor training, Conventional physiotherapy
- Keywords
- Cognitive-motor training, Executive function, Gait, Electroencephalography
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-motor trainingOther
Cognitive-motor training is that cognitive tasks incorporated into motor tasks.
Conventional physiotherapyOther
Conventional physiotherapy includes stretching, ROM exercise, strengthening exercise, and eye-hand coordination.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-motor training group | Experimental | Participants receive 16 sessions of cognitive-motor training. Receives: Other: Cognitive-motor training |
| Control group | Active comparator | Participants receive 16 sessions of conventional physiotherapy. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait variability
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%
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Gait speed
Using GAITRite system to measure gait speed
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Step length
Using GAITRite system to measure step length
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Step width
Using GAITRite system to measure step width
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Single support time
Using GAITRite system to measure single support time
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Double support time
Using GAITRite system to measure double support time
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Frontal Assessment Battery
The score ranged from 0 to 18. Higher scores show better executive function.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Stroop color and word test
Record numbers of corrected color words which the subject responds within 45 sec.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Digit span test
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.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Event-related potential - N2
Measure event-related potential through electroencephalography under single-task and dual-task paradigm.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Event-related potential - P300
Measure event-related potential through electroencephalography under single-task and dual-task paradigm.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Go/Nogo test
Behavioral test during measuring electroencephalography.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Trail making test
Trail making test contain part A and part B. Faster completing the test indicates better executive function.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Secondary outcomes (4)
Mini-Balance Evaluation Systems Test
Mini-Balance Evaluation Systems Test scores range from 0 to 28. Higher scores indicate better balance ability.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Montreal Cognitive Assessment
Montreal Cognitive Assessment ranges from 0 to 30. Higher scores reflect better cognitive performances.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Timed up and go test
Record time of performing timed up and go test
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Parkinson Disease Questionnaire
Parkinson Disease Questionnaire assess quality of life in people with Parkinson disease. Lower scores reflect higher quality of life.
Measured: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Mar 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588439
- Sponsor's protocol ID
- NYCU113006AF2
- Status last verified
- Jun 2025
- First submitted
- 5 Sep 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-motor Training on Brain Activity, Cognitive Function, and Walking Ability in People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT06588439
- Acronym / sponsor ID
- NYCU113006AF2
- Conditions
- Parkinson Disease
- Keywords
- Cognitive-motor training, Executive function, Gait, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-motor training group | Experimental | Other: Cognitive-motor trainingParticipants receive 16 sessions of cognitive-motor training. |
| Control group | Active comparator | Other: Conventional physiotherapyParticipants receive 16 sessions of conventional physiotherapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
- History of brain surgery (e.g. deep brain stimulation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-motor trainingCognitive-motor training is that cognitive tasks incorporated into motor tasks. | Other | Cognitive-motor training group |
| Conventional physiotherapyConventional physiotherapy includes stretching, ROM exercise, strengthening exercise, and eye-hand coordination. | Other | Control group |
Primary outcome
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%
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
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
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
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
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
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.
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.
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.
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.
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.
Go/Nogo test
Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention
Behavioral test during measuring electroencephalography.
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.
4 secondary outcomes
Mini-Balance Evaluation Systems Test
Time frame: 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
Timed up and go test
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-motor training and Conventional physiotherapy in people with Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ru Yang, PhD (+886228267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait variability (time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.