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NCT Number: NCT06598891

PAS Balance Training for Parkinson Disease (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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, 333, Taiwan

Location status: Recruiting

Location contact

Ya-Ju Chang, PhD

CONTACT

[email protected]

88632118800 ext. 5515

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Parkinson disease.

Exclusion criteria

  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

Treatment and study plan

Weight shift training and APA feedback

Procedure

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

Paired Associative Stimulation

Procedure

Use TMS combine ES to stimulate TA nerve and M1 cortical

Other names: PAS training

Primary outcomes

  1. Balance Performance

    Time frame: Baseline, 4 weeks and 8 weeks

    Measured by the duration the stance or stand can be maintained. Unit:second(s)

  2. COP Path Length in Balance Tasks

    Time frame: Baseline, 4 weeks and 8 weeks

    The total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability.

  3. COP Displacement in Balance Tasks

    Time frame: Baseline, 4 weeks and 8 weeks

    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)

  4. Motor Evoked Potentials (MEPs)

    Time frame: Baseline, 4 weeks and 8 weeks

    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)

  5. Intracortical Facilitation (ICF)

    Time frame: Baseline, 4 weeks and 8 weeks

    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.

  6. Intracortical Inhibition (ICI)

    Time frame: Baseline, 4 weeks and 8 weeks

    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.

  7. Walking Speed

    Time frame: Baseline, 4 weeks and 8 weeks

    The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).

  8. Step Length

    Time frame: Baseline, 4 weeks and 8 weeks

    The linear distance between the two ankles, typically expressed in centimeter(cm).

  9. Step Time

    Time frame: Baseline, 4 weeks and 8 weeks

    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.

Secondary outcomes

  1. COP Velocity in Balance Tasks

    Time frame: Baseline, 4 weeks and 8 weeks

    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)

  2. COP Area in Balance Tasks

    Time frame: Baseline, 4 weeks and 8 weeks

    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)

  3. Double Support Time

    Time frame: Baseline, 4 weeks and 8 weeks

    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.

  4. Single Support Time

    Time frame: Baseline, 4 weeks and 8 weeks

    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.

  5. Swing Time

    Time frame: Baseline, 4 weeks and 8 weeks

    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.

  6. Stance Time

    Time frame: Baseline, 4 weeks and 8 weeks

    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

  7. Cadence

    Time frame: Baseline, 4 weeks and 8 weeks

    The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.

Other outcomes

  1. Total UPDRS-III Score

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

Effect of Combined PAS Balance Training on Individuals With PD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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