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

Not Applicable
Recruiting
Conditions
Parkinson Disease
Interventions
Other: Weight shift training and APA feedback
Procedure: Paired associative stimulation
Registration Number
NCT06363071
Lead Sponsor
Chang Gung University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Stage 3: PD APA training groupWeight shift training and APA feedbackWeight shift training and APA feedback.
Stage 1:Healthy peoplePaired associative stimulationTo establish PAS baseline and reliability.
Stage 2:PD peoplePaired associative stimulationTo establish stage 3 training protocol.
Stage 3:PD PAS groupPaired associative stimulationUsing PAS to regulate brain plasticity
Primary Outcome Measures
NameTimeMethod
Balance PerformanceBaseline, 4 weeks and 8 weeks.

Measured by the duration the stance can be maintained. Unit:seconds(s)

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)

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 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 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.

Step LengthBaseline, 4 weeks and 8 weeks.

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

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.

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).

Secondary Outcome Measures
NameTimeMethod
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.

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)

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.

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)

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.

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.

Trial Locations

Locations (1)

Chang Gung University

🇨🇳

Taoyuan, Taiwan

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