Parkinson Disease(PD)NCT06355947
Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement
A study testing Cognitive cycling training and Cognitive treadmill training in people with Parkinson Disease(PD), run by Chang Gung University at 1 site in Taiwan.
Trial summary
Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- Cognitive cycling training and Cognitive treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2015to 31 Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease.
Who cannot join
- Musculoskeletal injuries on legs.
- Osteoporosis.
- PD subjects:
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cycling Induced Motor Cortex Plasticity and Functional Improvement -the Dual Task Evaluation Model for Parkinson Disease
Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.
Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.
Read more
Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.
The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.
The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.
The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.
- Conditions
- Parkinson Disease(PD)
- Being tested
- Cognitive cycling training, Cognitive treadmill training
- Keywords
- Gait, Cycling training, Treadmill training, Dual-task walking, Dual-task cycling
- 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 cycling trainingOther
Cycling training conducted with cognitive tasks
Cognitive treadmill trainingOther
Treadmill training conducted with cognitive tasks
| Study group | Role | What they receive |
|---|---|---|
| Stage 1:Healthy people | No intervention | To establish a baseline and ensure reliability, and to explore the relationship between dual-task gait performance and dual-task cycling |
| No Intervention: Stage 2:PD people | No intervention | To explore the relationship between dual-task gait and dual-task cycling performances in individuals with Parkinson's Disease (PD) |
| Stage 3:PD cycling training group | Experimental | Cycling training conducted with cognitive tasks Receives: Other: Cognitive cycling training |
| Stage 3: PD treadmill training group | Experimental | Treadmill training conducted with cognitive tasks Receives: Other: Cognitive treadmill training |
| Stage 3:PD Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Measured: Baseline, 4 weeks and 8 weeks
Step Length
The linear distance between the two ankles, typically expressed in centimeters(cm).
Measured: Baseline, 4 weeks and 8 weeks
Step Time
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Measured: Baseline, 4 weeks and 8 weeks
Power Spectral Density (PSD)
Quantifies the power of EEG signals within specific frequency bands (e.g., delta, theta, alpha, beta, and gamma) over a period.
Measured: Baseline, 4 weeks and 8 weeks.
Task Accuracy
The percentage of correct responses or actions made by participants in response to walking or cycling tasks.
Measured: Baseline, 4 weeks and 8 weeks.
Reaction Time
The duration between the onset of task start time and the participant's response to it, typically expressed in second (s).
Measured: Baseline, 4 weeks and 8 weeks.
Balance Performance
Measured by the duration the stance can be maintained, typically expressed second.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (6)
Double Support Time
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
Measured: Baseline, 4 weeks and 8 weeks
Single Support Time
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.
Measured: Baseline, 4 weeks and 8 weeks
Swing Time
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.
Measured: Baseline, 4 weeks and 8 weeks
Stance Time
The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds
Measured: Baseline, 4 weeks and 8 weeks
Cadence
The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.
Measured: Baseline, 4 weeks and 8 weeks
Heart rate
The number of heartbeats per minute on resting, walking or cycling tasks.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start7 Dec 2015
- Primary completion11 Sep 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease(PD)Studies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355947
- Sponsor's protocol ID
- 103-7445B
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling Induced Motor Cortex Plasticity and Functional Improvement -the Dual Task Evaluation Model for Parkinson Disease
- ClinicalTrials.gov ID
- NCT06355947
- Acronym / sponsor ID
- 103-7445B
- Conditions
- Parkinson Disease(PD)
- Keywords
- Gait, Cycling training, Treadmill training, Dual-task walking, Dual-task cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 10 Apr 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.
Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.
Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.
Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.
The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.
The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.
The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1:Healthy people | No intervention | –To establish a baseline and ensure reliability, and to explore the relationship between dual-task gait performance and dual-task cycling |
| No Intervention: Stage 2:PD people | No intervention | –To explore the relationship between dual-task gait and dual-task cycling performances in individuals with Parkinson's Disease (PD) |
| Stage 3:PD cycling training group | Experimental | Other: Cognitive cycling trainingCycling training conducted with cognitive tasks |
| Stage 3: PD treadmill training group | Experimental | Other: Cognitive treadmill trainingTreadmill training conducted with cognitive tasks |
| Stage 3:PD Control group | No intervention | –Control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson disease.
Key exclusion criteria (6 listed)
- Musculoskeletal injuries on legs.
- Osteoporosis.
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
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 cycling trainingCycling training conducted with cognitive tasks | Other | Stage 3:PD cycling training group |
| Cognitive treadmill trainingTreadmill training conducted with cognitive tasks | Other | Stage 3: PD treadmill training group |
Primary outcome
Walking Speed
Time frame: Baseline, 4 weeks and 8 weeks
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step Length
Time frame: Baseline, 4 weeks and 8 weeks
The linear distance between the two ankles, typically expressed in centimeters(cm).
Step Time
Time frame: Baseline, 4 weeks and 8 weeks
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Power Spectral Density (PSD)
Time frame: Baseline, 4 weeks and 8 weeks.
Quantifies the power of EEG signals within specific frequency bands (e.g., delta, theta, alpha, beta, and gamma) over a period.
Task Accuracy
Time frame: Baseline, 4 weeks and 8 weeks.
The percentage of correct responses or actions made by participants in response to walking or cycling tasks.
Reaction Time
Time frame: Baseline, 4 weeks and 8 weeks.
The duration between the onset of task start time and the participant's response to it, typically expressed in second (s).
Balance Performance
Time frame: Baseline, 4 weeks and 8 weeks
Measured by the duration the stance can be maintained, typically expressed second.
6 secondary outcomes
Double Support Time
Time frame: Baseline, 4 weeks and 8 weeks
Single Support Time
Time frame: Baseline, 4 weeks and 8 weeks
Swing Time
Time frame: Baseline, 4 weeks and 8 weeks
Stance Time
Time frame: Baseline, 4 weeks and 8 weeks
Cadence
Time frame: Baseline, 4 weeks and 8 weeks
Heart rate
Time frame: Baseline
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 10 Apr 2024.
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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 Cognitive cycling training and Cognitive treadmill training in people with Parkinson Disease(PD), run by Chang Gung 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 1 inclusion and 6 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 10 Apr 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?
Walking Speed (time frame: Baseline, 4 weeks and 8 weeks). The study lists 7 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 10 Apr 2024.