An interventional study of Weight shift training and APA feedback and Paired associative stimulation in Parkinson Disease, sponsored by Chang Gung University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Chang Gung University · Not applicable, Interventional, and Treatment
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.
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chang Gung University is the lead sponsor of 66 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Health subjects:
Exclusion Criteria:
PD subjects:
Inclusion Criteria:
- Clinical diagnosis of Parkinson disease.
Exclusion Criteria:
To establish PAS baseline and reliability.
Procedure: Paired associative stimulation
To establish stage 3 training protocol.
Procedure: Paired associative stimulation
Control group.
Weight shift training and APA feedback.
Other: Weight shift training and APA feedback
Using PAS to regulate brain plasticity
Procedure: Paired associative stimulation
Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
Also known as: • APA training group
Use TMS combine ES to stimulate TA nerve and M1 cortical
Also known as: PAS group
Balance Performance
Measured by the duration the stance can be maintained. Unit：seconds(s)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 4 weeks and 8 weeks.
Step Length
The linear distance between the two ankles, typically expressed in centimeter(cm).
Time frame: 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.
Time frame: Baseline, 4 weeks and 8 weeks.
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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, 4 weeks and 8 weeks.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Mar 2025, 33 months after the start.
Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 33 months is above that.
Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Chang Gung University