Early Onset Parkinson DiseaseNCT04033393
Dual-task Performance in Young-onset PD
A study testing Game based dual-task training and Treadmill training in people with Early Onset Parkinson Disease and Early Stage Parkinson Disease, run by National Yang Ming Chiao Tung University.
Trial summary
This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Onset Parkinson Disease, Early Stage Parkinson Disease
- What is being tested?
- Game based dual-task training and Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as PD and Hoehn and Yahr stage between 1~3
- Age between 20 to 80
- Able to walk 10 m independently without an assistive device
- A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
- In stable medical condition allowing participation in the testing protocol and intervention
Who cannot join
- Any comorbidity or disability other than PD that would preclude gait training
- Any uncontrolled health condition for which exercise was contraindicated
- Any neurological or orthopedic disease that might interfere with the study
- Server freezing of gait, FOG questionnaire > 15
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects
This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.
- Being tested
- Game based dual-task training, Treadmill training
- Keywords
- Executive function, Dual-task performance, Dual-task training
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game based dual-task trainingOther
Participants in the experimental group will receive game based dual-task training with a treadmill
Treadmill trainingOther
Participants in the control group will receive treadmill training
| Study group | Role | What they receive |
|---|---|---|
| Game based dual-task training group | Experimental | Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks Receives: Other: Game based dual-task training |
| Treadmill training group | Active comparator | Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks Receives: Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task walking performance
To evaluate gait parameters while doing dual-task walking
Measured: Change from baseline at 8 weeks
Secondary outcomes (10)
Single walking performance
To evaluate gait parameters while doing single walking
Measured: Change from baseline at 8 weeks
Timed up and go test
To evaluate functional walking ability
Measured: Change from baseline at 8 weeks
Parkinson's Disease Questionnaire 39
To evaluate the quality of life
Measured: Change from baseline at 8 weeks
Frontal lobe battery test-Chinese version
To evaluate executive function
Measured: Change from baseline at 8 weeks
Trail-making test
To evaluate executive function
Measured: Change from baseline at 8 weeks
Stroop color and word test-Chinese version
To evaluate executive function
Measured: Change from baseline at 8 weeks
Verbal fluency test-Chinese version
To evaluate executive function
Measured: Change from baseline at 8 weeks
Digit span test
To evaluate executive function
Measured: Change from baseline at 8 weeks
Dual-task costs
To compare the cost between doing dual task and single task
Measured: Change from baseline at 8 weeks
Functional near-infrared spectroscopy
To evaluate the changes of blood perfusion in frontal lobe
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Onset Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- 40 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
- NCT04033393
- Sponsor's protocol ID
- 2019-05-005C
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects
- ClinicalTrials.gov ID
- NCT04033393
- Acronym / sponsor ID
- 2019-05-005C
- Keywords
- Executive function, Dual-task performance, Dual-task training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 26 Jul 2019 (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.
This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game based dual-task training group | Experimental | Other: Game based dual-task trainingParticipants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks |
| Treadmill training group | Active comparator | Other: Treadmill trainingParticipants in treadmill training group will do treadmill training, 3 times per week for 8 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed as PD and Hoehn and Yahr stage between 1~3
- Age between 20 to 80
- Able to walk 10 m independently without an assistive device
- A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
- In stable medical condition allowing participation in the testing protocol and intervention
Key exclusion criteria (4 listed)
- Any comorbidity or disability other than PD that would preclude gait training
- Any uncontrolled health condition for which exercise was contraindicated
- Any neurological or orthopedic disease that might interfere with the study
- Server freezing of gait, FOG questionnaire > 15
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 |
|---|---|---|
| Game based dual-task trainingParticipants in the experimental group will receive game based dual-task training with a treadmill | Other | Game based dual-task training group |
| Treadmill trainingParticipants in the control group will receive treadmill training | Other | Treadmill training group |
Primary outcome
Dual-task walking performance
Time frame: Change from baseline at 8 weeks
To evaluate gait parameters while doing dual-task walking
10 secondary outcomes
Single walking performance
Time frame: Change from baseline at 8 weeks
Timed up and go test
Time frame: Change from baseline at 8 weeks
Parkinson's Disease Questionnaire 39
Time frame: Change from baseline at 8 weeks
Frontal lobe battery test-Chinese version
Time frame: Change from baseline at 8 weeks
Trail-making test
Time frame: Change from baseline at 8 weeks
Stroop color and word test-Chinese version
Time frame: Change from baseline at 8 weeks
Verbal fluency test-Chinese version
Time frame: Change from baseline at 8 weeks
Digit span test
Time frame: Change from baseline at 8 weeks
Dual-task costs
Time frame: Change from baseline at 8 weeks
Functional near-infrared spectroscopy
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
Related trials for Early Onset Parkinson Disease
Active, not recruitingPhase 2
A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
Parkinson Disease, Parkinson Disease 6, Early-Onset
Not yet recruitingPhase 1
AAV2-hAADC for Parkinson's Disease (PDCS-01)
Parkinson's Disease (PD), Early Onset Parkinson Disease
Not yet recruitingPhase 3
Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsules in Patients With Early-Onset Parkinson's Disease
Parkinson's Disease (PD), Parkinson Disease 6, Early-Onset
Recruiting
Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity
Alzheimer Disease, Early Onset, Parkinson Disease
Recruiting
Neuropsychological Profiles and Musical Engagement in Parkinson's and Alzheimer's Disease
Alzheimer Disease, Early Onset, Parkinsons Disease with Dementia
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Game based dual-task training and Treadmill training in people with Early Onset Parkinson Disease and Early Stage Parkinson Disease, run by National Yang Ming Chiao Tung University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yearu, Ph.D. (+88628267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task walking performance (time frame: Change from baseline at 8 weeks). 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 29 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.