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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06363071
Other study ID # 202000495A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 13, 2022
Est. completion date May 31, 2025

Study information

Verified date April 2024
Source Chang Gung University
Contact Ya-Ju Chang, PhD
Phone +88632118800
Email yjchang@mail.cgu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Health subjects: Exclusion Criteria: - Musculoskeletal injuries on legs. - Osteoporosis. PD subjects: Inclusion Criteria: - Clinical diagnosis of Parkinson disease. Exclusion Criteria: - Musculoskeletal injuries on legs - Osteoporosis. - Any peripheral or central nervous system injury or disease patients.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Weight shift training and APA feedback
Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
Procedure:
Paired associative stimulation
Use TMS combine ES to stimulate TA nerve and M1 cortical

Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Balance Performance Measured by the duration the stance can be maintained. Unit:seconds(s) Baseline, 4 weeks and 8 weeks.
Primary 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) Baseline, 4 weeks and 8 weeks.
Primary 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) Baseline, 4 weeks and 8 weeks.
Primary 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) Baseline, 4 weeks and 8 weeks.
Primary 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. Baseline, 4 weeks and 8 weeks.
Primary 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. Baseline, 4 weeks and 8 weeks.
Primary Walking Speed The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s). Baseline, 4 weeks and 8 weeks.
Primary Step Length The linear distance between the two ankles, typically expressed in centimeter(cm). Baseline, 4 weeks and 8 weeks.
Primary 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. Baseline, 4 weeks and 8 weeks.
Secondary 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) Baseline, 4 weeks and 8 weeks.
Secondary 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) Baseline, 4 weeks and 8 weeks.
Secondary 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. Baseline, 4 weeks and 8 weeks.
Secondary 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. Baseline, 4 weeks and 8 weeks.
Secondary 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. Baseline, 4 weeks and 8 weeks.
Secondary 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 Baseline, 4 weeks and 8 weeks.
Secondary Cadence The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute. Baseline, 4 weeks and 8 weeks.
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