Clinical trial NCT06363071: APA and PAS Training for Gait Initiation in Parkinson's Disease
Official title: Gait-initiation Related APA Training in Individuals With Parkinson Disease -Explicit Training and Paired Associative Stimulation(PAS) Priming
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Gait Initiation
Balance training
Anticipatory postural adjustments
Paired associative stimulation (PAS)
Transcranial magnetic stimulation (TMS)
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Health subjects:

Exclusion Criteria:

* Musculoskeletal injuries on legs.
* Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

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

Primary outcomes:
measure: Balance Performance
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: COP Path Length in Balance Tasks
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: COP Displacement in Balance Tasks
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Motor Evoked Potentials (MEPs)
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Intracortical Facilitation (ICF)
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Intracortical Inhibition (ICI)
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Walking Speed
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Step Length
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Step Time
timeFrame: Baseline, 4 weeks and 8 weeks.
Secondary outcomes:
measure: COP Velocity in Balance Tasks
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: COP Area in Balance Tasks
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Double Support Time
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Single Support Time
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Swing Time
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Stance Time
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Cadence
timeFrame: Baseline, 4 weeks and 8 weeks.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: