APA and PAS Training for Gait Initiation in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Gait-initiation Related APA Training in Individuals With Parkinson Disease -Explicit Training and Paired Associative Stimulation(PAS) Priming

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363071
• Other study ID #: 202000495A3
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Parkinson Disease

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.