Parkinson DiseaseNCT06363071
APA and PAS Training for Gait Initiation in Parkinson's Disease
A study testing Weight shift training and APA feedback and Paired associative stimulation in people with Parkinson Disease, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. 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
- What is being tested?
- Weight shift training and APA feedback and Paired associative stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jun 2022to 31 May 2025
- 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.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Official title: Gait-initiation Related APA Training in Individuals With Parkinson Disease -Explicit Training and Paired Associative Stimulation(PAS) Priming
Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability.
Read the detailed description
Research on Brain Excitability and Balance Function Performance in Patients with Parkinson's Disease and Related Physical Therapy Methods
Research indicates that non-motor disorders and cognitive impairments are prevalent in most patients with Parkinson's disease. These include balance issues, postural instability, impaired cognitive functions like working memory and executive functions, and gait instability. Additionally, electrophysiological phenomena in Parkinson's disease patients reveal abnormal central excitatory and inhibitory responses compared to healthy individuals.
This experiment seeks to investigate the link between motor performance and brain excitability in patients with Parkinson's disease. Previous studies suggest that associative electrical stimulation, used to regulate sensorimotor information integration, can enhance brain excitability in both healthy individuals and those with Parkinson's disease. However, the optimal parameters for this stimulation remain uncertain.
Furthermore, balance exercise training can improve motor performance in Parkinson's disease patients. This study aims to determine if various designs of associative electrical stimulation parameters can help these patients achieve optimal brain excitability regulation. The combined approach of this stimulation and balance exercise training aims to maintain and improve the patients' functional performance, thereby enhancing the safety of their daily activities.
- Conditions
- Parkinson Disease
- Being tested
- Weight shift training and APA feedback, Paired associative stimulation
- Keywords
- Gait Initiation, Balance training, Anticipatory postural adjustments, Paired associative stimulation (PAS), Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight shift training and APA feedbackOther
Also called • APA training group
Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
Paired associative stimulationProcedure or surgery
Also called PAS group
Use TMS combine ES to stimulate TA nerve and M1 cortical
| Study group | Role | What they receive |
|---|---|---|
| Stage 1:Healthy people | Experimental | To establish PAS baseline and reliability. Receives: Procedure: Paired associative stimulation |
| Stage 2:PD people | Experimental | To establish stage 3 training protocol. Receives: Procedure: Paired associative stimulation |
| Stage 3:PD people | No intervention | Control group. |
| Stage 3: PD APA training group | Experimental | Weight shift training and APA feedback. Receives: Other: Weight shift training and APA feedback |
| Stage 3:PD PAS group | Experimental | Using PAS to regulate brain plasticity Receives: Procedure: Paired associative stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance
Measured by the duration the stance can be maintained. Unit：seconds(s)
Measured: Baseline, 4 weeks and 8 weeks.
COP Path Length in Balance Tasks
The total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability. Unit：millimeters(mm)
Measured: Baseline, 4 weeks and 8 weeks.
COP Displacement in Balance Tasks
Measures of COP movement in the anterior-posterior (AP) and medial-lateral (ML) directions, offering insights into the directional tendencies of balance control. Unit：millimeters(mm)
Measured: Baseline, 4 weeks and 8 weeks.
Motor Evoked Potentials (MEPs)
MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit：millivolts (mV)
Measured: Baseline, 4 weeks and 8 weeks.
Intracortical Facilitation (ICF)
ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.
Measured: Baseline, 4 weeks and 8 weeks.
Intracortical Inhibition (ICI)
ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.
Measured: Baseline, 4 weeks and 8 weeks.
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 centimeter(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.
Secondary outcomes (7)
COP Velocity in Balance Tasks
The speed at which the COP moves, calculated over the duration of the balance task. Higher velocities may reflect more dynamic balance adjustments or instability. Unit：millimeters per second(mm/s)
Measured: Baseline, 4 weeks and 8 weeks.
COP Area in Balance Tasks
The area covered by the COP trajectory during the balance task, providing an estimate of the sway envelope. A larger area might indicate poorer balance control. Unit：square millimeters(mm^2)
Measured: Baseline, 4 weeks and 8 weeks.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start13 Jun 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (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.
- 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
- 100 participants (estimated)
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
- NCT06363071
- Sponsor's protocol ID
- 202000495A3
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait-initiation Related APA Training in Individuals With Parkinson Disease -Explicit Training and Paired Associative Stimulation(PAS) Priming
- ClinicalTrials.gov ID
- NCT06363071
- Acronym / sponsor ID
- 202000495A3
- Conditions
- Parkinson Disease
- Keywords
- Gait Initiation, Balance training, Anticipatory postural adjustments, Paired associative stimulation (PAS), Transcranial magnetic stimulation (TMS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 12 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.
Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability.
Detailed description
Research on Brain Excitability and Balance Function Performance in Patients with Parkinson's Disease and Related Physical Therapy Methods
Research indicates that non-motor disorders and cognitive impairments are prevalent in most patients with Parkinson's disease. These include balance issues, postural instability, impaired cognitive functions like working memory and executive functions, and gait instability. Additionally, electrophysiological phenomena in Parkinson's disease patients reveal abnormal central excitatory and inhibitory responses compared to healthy individuals.
This experiment seeks to investigate the link between motor performance and brain excitability in patients with Parkinson's disease. Previous studies suggest that associative electrical stimulation, used to regulate sensorimotor information integration, can enhance brain excitability in both healthy individuals and those with Parkinson's disease. However, the optimal parameters for this stimulation remain uncertain.
Furthermore, balance exercise training can improve motor performance in Parkinson's disease patients. This study aims to determine if various designs of associative electrical stimulation parameters can help these patients achieve optimal brain excitability regulation. The combined approach of this stimulation and balance exercise training aims to maintain and improve the patients' functional performance, thereby enhancing the safety of their daily activities.
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 | Experimental | Procedure: Paired associative stimulationTo establish PAS baseline and reliability. |
| Stage 2:PD people | Experimental | Procedure: Paired associative stimulationTo establish stage 3 training protocol. |
| Stage 3:PD people | No intervention | –Control group. |
| Stage 3: PD APA training group | Experimental | Other: Weight shift training and APA feedbackWeight shift training and APA feedback. |
| Stage 3:PD PAS group | Experimental | Procedure: Paired associative stimulationUsing PAS to regulate brain plasticity |
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 |
|---|---|---|
| Weight shift training and APA feedbackAlso: • APA training groupUse COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training. | Other | Stage 3: PD APA training group |
| Paired associative stimulationAlso: PAS groupUse TMS combine ES to stimulate TA nerve and M1 cortical | Procedure or surgery | Stage 1:Healthy people, Stage 2:PD people, Stage 3:PD PAS group |
Primary outcome
Balance Performance
Time frame: Baseline, 4 weeks and 8 weeks.
Measured by the duration the stance can be maintained. Unit：seconds(s)
COP Path Length in Balance Tasks
Time frame: Baseline, 4 weeks and 8 weeks.
The total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability. Unit：millimeters(mm)
COP Displacement in Balance Tasks
Time frame: Baseline, 4 weeks and 8 weeks.
Measures of COP movement in the anterior-posterior (AP) and medial-lateral (ML) directions, offering insights into the directional tendencies of balance control. Unit：millimeters(mm)
Motor Evoked Potentials (MEPs)
Time frame: Baseline, 4 weeks and 8 weeks.
MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit：millivolts (mV)
Intracortical Facilitation (ICF)
Time frame: Baseline, 4 weeks and 8 weeks.
ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.
Intracortical Inhibition (ICI)
Time frame: Baseline, 4 weeks and 8 weeks.
ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.
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 centimeter(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.
7 secondary outcomes
COP Velocity in Balance Tasks
Time frame: Baseline, 4 weeks and 8 weeks.
COP Area in Balance Tasks
Time frame: Baseline, 4 weeks and 8 weeks.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight shift training and APA feedback and Paired associative stimulation in people with Parkinson Disease, 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: status not confirmed, as of the sponsor's last update on 12 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ju Chang, PhD (+88632118800 ext. 5515, yjchang@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Performance (time frame: Baseline, 4 weeks and 8 weeks.). The study lists 9 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 Apr 2024.