Parkinson's DiseaseNCT03623841
Training With Exergame and Treadmill on Executive Function and Dual-task Performance
A study testing Dual-task training and Treadmill training in people with Parkinson's Disease and Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study aimed to investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke 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 50 to 80 years
- Conditions the study is for
- Parkinson's Disease, Stroke
- What is being tested?
- Dual-task training and Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2018to 9 Aug 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 50 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 50 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
1 site in 1 country.
About this study
Official title: Effects of Dual-task Training With Exergame and Treadmill on Executive Function, Dual-task Performance and Cortical Activation in Individuals With Parkinson's Disease and Stroke
This study aimed to investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.
Read the detailed description
Background: In daily living, walking usually combines with cognitive or motor dual tasks. For individuals with Parkinson's disease (PD), gait performance becomes worse while doing dual tasks, which may due to insufficient executive function. Declined executive function may occur in early stage of PD. For those with stroke, impaired dual-task performance also exists. Although 75% of patients with stroke may suffer from impaired executive function, impaired dual-task performance correlates with declined executive function directly or not still unknown. Undoubtedly, impaired executive function decreases their daily activities. Recently, dual-task training by walking with secondary tasks resulted in improvement of single or dual-task gait performance in individuals with PD. As for stroke, dual-task training performed in walking with secondary tasks and resulted in improvement of single or dual-task gait performance. However, previous studies less mentioned about combine cognitive and motor tasks simultaneously with gait training. While dual-task training with exergame and treadmill can include cognitive and motor tasks simultaneously while walking. Thus, whether dual-task training with exergame and treadmill can improve executive function and dual-task performance in individuals with PD and stroke is worth to investigate. Purposes: To investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training. Methods: This research will be implemented in two phases. First phase will include 50 subjects with PD and the second phase will include 50 subjects with stroke. After pre-test, subjects will be randomly assigned into either the experimental group or the control group. Subjects in the experimental group will receive 24 sessions dual-task training with exergame and treadmill in 8 weeks; while the control group will receive treadmill training only in same frequency. Each session lasts an hour. Primary outcomes include general cognitive performance, executive function, dual-task performance, dual-task effects and cortical activation. Secondary outcomes include single walking performance, functional walking and quality of life. Statistical analysis: Descriptive statistics will be generated for all variables. Intergroup differences among baseline characteristics will be evaluated by independent t test or χ2 analysis. Primary and secondary outcomes will be analyzed by two-way repeated measures ANOVA and post-hoc test. The correlation between change values of executive function and dual-task performance will be evaluated by Pearson correlation coefficient. Statistical significance will set at P<0.05.
- Conditions
- Parkinson's Disease, Stroke
- Being tested
- Dual-task training, Treadmill training
- Keywords
- Executive function, Dual-task performance, Dual-task training
- Medical subject headings
- Parkinson Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task trainingOther
Participants in experimental group will do dual-task training via exer-game which combined with treadmill
Treadmill trainingOther
Participants in control group will do treadmill training only
| Study group | Role | What they receive |
|---|---|---|
| Dual-task training group | Experimental | Participants in dual-task training group will execute dual-task training via exer-game which combined with treadmill, 3 times per week, least 8 weeks. Receives: Other: Dual-task training |
| Treadmill training group | Active comparator | Participants in treadmill training group will do treadmill training only, 3 times per week, least 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 effects/ costs
to compare the cost between doing dual task and single task
Measured: 2 months
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 posted9 Aug 2018
- Study start9 Nov 2018
- Primary completion30 Jun 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's 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
- 28 participants (actual)
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
- NCT03623841
- Sponsor's protocol ID
- 17MMHIS193
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2018
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou JH, Wang RY, Liu YT, Cheng SJ, Liu HH, Yang YR. Effects of dual-task training on gait variability in individuals with Parkinson's disease: A randomized controlled trial. J Sci Med Sport. 2025 Dec;28(12):1012-1018. doi: 10.1016/j.jsams.2025.06.009. Epub 2025 Jun 20.
PubMed 40610273Zhou JH, Wang RY, Liu YT, Cheng SJ, Liu HH, Yang YR. Improving Executive Function and Dual-Task Cost in Parkinson Disease: A Randomized Controlled Trial. J Neurol Phys Ther. 2024 Oct 1;48(4):188-197. doi: 10.1097/NPT.0000000000000489. Epub 2024 Sep 17.
PubMed 39164804
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual-task Training With Exergame and Treadmill on Executive Function, Dual-task Performance and Cortical Activation in Individuals With Parkinson's Disease and Stroke
- ClinicalTrials.gov ID
- NCT03623841
- Acronym / sponsor ID
- 17MMHIS193
- Conditions
- Parkinson's Disease, Stroke
- Keywords
- Executive function, Dual-task performance, Dual-task training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 9 Aug 2018 (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 dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.
Detailed description
Background: In daily living, walking usually combines with cognitive or motor dual tasks. For individuals with Parkinson's disease (PD), gait performance becomes worse while doing dual tasks, which may due to insufficient executive function. Declined executive function may occur in early stage of PD. For those with stroke, impaired dual-task performance also exists. Although 75% of patients with stroke may suffer from impaired executive function, impaired dual-task performance correlates with declined executive function directly or not still unknown. Undoubtedly, impaired executive function decreases their daily activities. Recently, dual-task training by walking with secondary tasks resulted in improvement of single or dual-task gait performance in individuals with PD. As for stroke, dual-task training performed in walking with secondary tasks and resulted in improvement of single or dual-task gait performance. However, previous studies less mentioned about combine cognitive and motor tasks simultaneously with gait training. While dual-task training with exergame and treadmill can include cognitive and motor tasks simultaneously while walking. Thus, whether dual-task training with exergame and treadmill can improve executive function and dual-task performance in individuals with PD and stroke is worth to investigate. Purposes: To investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training. Methods: This research will be implemented in two phases. First phase will include 50 subjects with PD and the second phase will include 50 subjects with stroke. After pre-test, subjects will be randomly assigned into either the experimental group or the control group. Subjects in the experimental group will receive 24 sessions dual-task training with exergame and treadmill in 8 weeks; while the control group will receive treadmill training only in same frequency. Each session lasts an hour. Primary outcomes include general cognitive performance, executive function, dual-task performance, dual-task effects and cortical activation. Secondary outcomes include single walking performance, functional walking and quality of life. Statistical analysis: Descriptive statistics will be generated for all variables. Intergroup differences among baseline characteristics will be evaluated by independent t test or χ2 analysis. Primary and secondary outcomes will be analyzed by two-way repeated measures ANOVA and post-hoc test. The correlation between change values of executive function and dual-task performance will be evaluated by Pearson correlation coefficient. Statistical significance will set at P<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-task training group | Experimental | Other: Dual-task trainingParticipants in dual-task training group will execute dual-task training via exer-game which combined with treadmill, 3 times per week, least 8 weeks. |
| Treadmill training group | Active comparator | Other: Treadmill trainingParticipants in treadmill training group will do treadmill training only, 3 times per week, least 8 weeks. |
Who may qualify
- Ages
- 50 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 50 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 |
|---|---|---|
| Dual-task trainingParticipants in experimental group will do dual-task training via exer-game which combined with treadmill | Other | Dual-task training group |
| Treadmill trainingParticipants in control group will do treadmill training only | 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 effects/ costs
Time frame: 2 months
Functional near-infrared spectroscopy
Time frame: Change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 40610273Zhou JH, Wang RY, Liu YT, Cheng SJ, Liu HH, Yang YR. Effects of dual-task training on gait variability in individuals with Parkinson's disease: A randomized controlled trial. J Sci Med Sport. 2025 Dec;28(12):1012-1018. doi: 10.1016/j.jsams.2025.06.009. Epub 2025 Jun 20.
- Derived from this study: PubMed 39164804Zhou JH, Wang RY, Liu YT, Cheng SJ, Liu HH, Yang YR. Improving Executive Function and Dual-Task Cost in Parkinson Disease: A Randomized Controlled Trial. J Neurol Phys Ther. 2024 Oct 1;48(4):188-197. doi: 10.1097/NPT.0000000000000489. Epub 2024 Sep 17.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task training and Treadmill training in people with Parkinson's Disease and Stroke, 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 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: finished, as of the sponsor's last update on 9 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT03623841, which also lists 2 linked publications.
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 9 Jul 2024.