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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06363071
Enrollment
100
Registered
2024-04-12
Start date
2022-06-13
Completion date
2025-05-31
Last updated
2024-04-12

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

Conditions

Parkinson Disease

Keywords

Gait Initiation, Balance training, Anticipatory postural adjustments, Paired associative stimulation (PAS), Transcranial magnetic stimulation (TMS)

Brief 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.

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.

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
Yes

Inclusion criteria

Health subjects:

Exclusion criteria

* Musculoskeletal injuries on legs. * Osteoporosis. PD subjects: Inclusion Criteria: \- Clinical diagnosis of Parkinson disease.

Design outcomes

Primary

MeasureTime frameDescription
Step TimeBaseline, 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.
COP Path Length in Balance TasksBaseline, 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. Unit:millimeters(mm)
COP Displacement in Balance TasksBaseline, 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:millimeters(mm)
Motor Evoked Potentials (MEPs)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)
Intracortical Facilitation (ICF)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.
Intracortical Inhibition (ICI)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.
Walking SpeedBaseline, 4 weeks and 8 weeks.The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step LengthBaseline, 4 weeks and 8 weeks.The linear distance between the two ankles, typically expressed in centimeter(cm).
Balance PerformanceBaseline, 4 weeks and 8 weeks.Measured by the duration the stance can be maintained. Unit:seconds(s)

Secondary

MeasureTime frameDescription
COP Area in Balance TasksBaseline, 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 millimeters(mm\^2)
Double Support TimeBaseline, 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.
Single Support TimeBaseline, 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.
Swing TimeBaseline, 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.
Stance TimeBaseline, 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
CadenceBaseline, 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.
COP Velocity in Balance TasksBaseline, 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:millimeters per second(mm/s)

Countries

Taiwan

Contacts

Primary ContactYa-Ju Chang, PhD
yjchang@mail.cgu.edu.tw+88632118800

Outcome results

None listed

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