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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Weight shift training and APA feedback; Procedure: Paired associative stimulation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Ju Chang, PhD; Phone Number: 5515 +88632118800; Email: yjchang@mail.cgu.edu.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung University
    • Contact: Ya-Ju Chang, PhD; Phone Number: 5515 88632118800; Email: yjchang@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1:Healthy people; To establish PAS baseline and reliability.	Procedure: Paired associative stimulation; Use TMS combine ES to stimulate TA nerve and M1 cortical; Other Names: PAS group
Experimental: Stage 2:PD people; To establish stage 3 training protocol.	Procedure: Paired associative stimulation; Use TMS combine ES to stimulate TA nerve and M1 cortical; Other Names: PAS group
No Intervention: Stage 3:PD people; Control group.
Experimental: Stage 3: PD APA training group; Weight shift training and APA feedback.	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.; Other Names: • APA training group
Experimental: Stage 3:PD PAS group; Using PAS to regulate brain plasticity	Procedure: Paired associative stimulation; Use TMS combine ES to stimulate TA nerve and M1 cortical; Other Names: PAS group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance Performance	Measured by the duration the stance can be maintained. Unit：seconds(s)	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)	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)	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)	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.	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.	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).	Baseline, 4 weeks and 8 weeks.
Step Length	The linear distance between the two ankles, typically expressed in centimeter(cm).	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.	Baseline, 4 weeks and 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Transcranial magnetic stimulation (TMS); Balance training; Gait Initiation; Anticipatory postural adjustments; Paired associative stimulation (PAS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 202000495A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No