Evaluation of neuroplasticity and biomarker after neurorehabilitation for Parkinson's disease

JRCT ID: jRCT1032240550

Registered date:13/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 12/01/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Compared to regular rehabilitation aimed at maintaining daily life and ADL, the rehabilitation in this study focuses on active aerobic exercise, mainly in the sitting and standing positions. Meanwhile, the therapist performs muscle stretches and alignment corrections (body segments and body axes) according to the individual needs of the patient, as well as whole-body coordination, including increasing or decreasing the amount of assistance for unstable elements. In this respect, it differs from the patient simply doing exercises on his or her own.

Outcome(s)

• Primary Outcome: Neuroplasticity determined by comparing head MRI before and after neurorehabilitation and molecular mechanisms related to neuroplasticity determined by integrated analysis of changes in blood exosome profiles

Secondary Outcome

1) Neuroplasticity obtained by comparing head MRI before and after neurorehabilitation
2) Changes in blood exosome profile (microRNA, mRNA, protein, metabolites, etc.)
3) Changes in PD-related evaluation items
HDS-R, MMSE
UPDRS part I, II, III, IV
Beck Depression Scale
Wearing-off Questionnaires19
Sit to stand-5
Time up and go test
Functional reach test
Mini-Bestest
Falls efficacy scale-International

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) PD patients diagnosed by a neurologist based on the UK Parkinson's Disease Society Brain Bank
2) PD patients currently attending our outpatient clinic
3) Yahr severity level 3 or less

Exclude criteria

1) Patients under 20 years of age
2) Patients with moderate or higher cognitive function (MMSE < 24)
3) Patients with contraindications for MRI due to pacemakers, metal in the body, or claustrophobia
4) Patients for whom aerobic exercise is deemed inappropriate due to unstable hypertension, diabetes, cerebrovascular disease, heart disease (ischemic heart disease, arrhythmia, heart failure, etc.), peripheral arterial occlusive disease, orthostatic hypotension, pulmonary disease, etc.
5) Patients with neurological or orthopedic diseases who cannot undergo rehabilitation using stretching or an exercise bike
6) Patients with mental disorders such as depression diagnosed by a psychiatrist, or those with significant mental symptoms

Related Information

• Primary Sponsor: Ueno Yuji
• Secondary Sponsor: Scholarship donations to the Department of Neurology,Yamanashi University FY2023 Community Contribution Promotion Project