PAS Balance Training for Parkinson Disease (PD)

Effect of Combined PAS Balance Training on Individuals With PD

Gait initiation (GI) difficulty is a common problem in individuals with Parkinson's disease (PD), often linked to impaired anticipatory postural adjustments (APA). Currently, there are no targeted rehabilitation programs designed specifically for GI-related APA in PD patients. Research has shown that while motor learning deficits are common in PD, explicit learning is better preserved than implicit learning. Therefore, a GI-related APA training system using an explicit learning model could be particularly effective for this population.

During motor learning, long-term potentiation (LTP) increases the excitability of the primary motor cortex. Paired associative stimulation (PAS) has been demonstrated to induce LTP-like changes in the motor cortex, making it a potential priming method to enhance motor learning. However, the priming effect of PAS targeted at leg muscles and the motor cortex on motor learning related to GI-APA has not been previously studied.

The objectives of this study are:

1. To investigate the effects of explicit and implicit training on GI-related APA.
2. To evaluate the priming effect of PAS on GI-related APA training and the associated plasticity changes in the motor cortex.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

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: No

Description

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD APA training group; Weight shift training and APA feedback.	Procedure: 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
Experimental: 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 training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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：millimeter 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 millimeter(mm^2)	Baseline, 4 weeks and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total UPDRS-III Score	The Unified Parkinson's Disease Rating Scale (UPDRS) Part III, also known as the UPDRS-III or the Motor Examination, is a critical component of the UPDRS used to assess the motor symptoms of Parkinson's disease (PD). To provide a comprehensive assessment of motor function in individuals with Parkinson's disease, covering aspects such as bradykinesia (slowness of movement), rigidity, tremors, and postural instability. The UPDRS-III consists of 14 items, each rated on a scale from 0 (normal) to 4 (severe), with a total possible score range from 0 to 108. Higher scores indicate greater motor impairment.	Baseline

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Balance training; Motor learning; Gait Initiation; Paired associative stimulation (PAS); Anticipatory postural adjustment (APA)
• 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: PD_002

Drug and device information, study documents

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