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PAS Balance Training for Parkinson Disease (PD)

Effect of Combined PAS Balance Training on Individuals With PD

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06598891
Enrollment
60
Registered
2024-09-19
Start date
2024-10-09
Completion date
2026-05-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PD - Parkinson's Disease

Keywords

Gait Initiation, Paired associative stimulation (PAS), Balance training, Motor learning, Anticipatory postural adjustment (APA)

Brief summary

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.

Interventions

Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.

Use TMS combine ES to stimulate TA nerve and M1 cortical

Sponsors

Chang Gung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Clinical diagnosis of Parkinson disease.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Step TimeBaseline, 4 weeks and 8 weeksThe 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.
Balance PerformanceBaseline, 4 weeks and 8 weeksMeasured by the duration the stance or stand can be maintained. Unit:second(s)
COP Path Length in Balance TasksBaseline, 4 weeks and 8 weeksThe total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability.
COP Displacement in Balance TasksBaseline, 4 weeks and 8 weeksMeasures 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)
Motor Evoked Potentials (MEPs)Baseline, 4 weeks and 8 weeksMEPs 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)
Intracortical Facilitation (ICF)Baseline, 4 weeks and 8 weeksICF 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.
Intracortical Inhibition (ICI)Baseline, 4 weeks and 8 weeksICI 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.
Walking SpeedBaseline, 4 weeks and 8 weeksThe time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step LengthBaseline, 4 weeks and 8 weeksThe linear distance between the two ankles, typically expressed in centimeter(cm).

Secondary

MeasureTime frameDescription
COP Velocity in Balance TasksBaseline, 4 weeks and 8 weeksThe 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)
COP Area in Balance TasksBaseline, 4 weeks and 8 weeksThe 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)
Double Support TimeBaseline, 4 weeks and 8 weeksThe 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.
Single Support TimeBaseline, 4 weeks and 8 weeksThe 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.
Swing TimeBaseline, 4 weeks and 8 weeksThe 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.
Stance TimeBaseline, 4 weeks and 8 weeksThe 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
CadenceBaseline, 4 weeks and 8 weeksThe number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.

Other

MeasureTime frameDescription
Total UPDRS-III ScoreBaselineThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026