Overview
In this study, the investigators aim to evaluate the clinical efficacy and cost-effectiveness of MARS-PD. Conventional, usual care will be used as the comparator because this trial aims to assess the add-on effect of MARS-PD. The investigators hypothesize that the complex therapy will relieve motor and nonmotor symptoms, improve gait performance, and enhance neuroplasticity in PD patients, and will be safe and cost-effective.
Description
This study is a randomized controlled trial conducted at a single center with raters blinded to the intervention. We will look at the clinical effect of MARS-PD, consisting of 16 interventions over an 8-week period, in 88 individuals with Parkinson's disease. Patients will be assigned to either the experimental (n=44) or control (n=44) groups at random. he experimental group will receive the MARS intervention, while the control group will receive usual care only. The treatment duration is 8 weeks, followed by a 12-week follow-up. The primary outcome is the change in MDS-UPDRS Part III (Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III) score from baseline to 8 weeks. Secondary outcomes include assessments such as MDS-UPDRS, International Physical Activity Questionnaire Short Form, Parkinson Self Questionnaire, Parkinson's Disease Sleep Scale, Timed Up and Go test, GAITRite metrics, Functional Near-Infrared Spectroscopy measurements, smart band results, gut microbiome composition and diversity, and iris connective tissue texture.
Eligibility
Inclusion Criteria:
- 45 to 75 years of age
- Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria
- Hoehn and Yahr scale stage I to III
- Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form
Exclusion Criteria:
- Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) more than three-fold the upper limit of normal in the research institute's laboratory, heart failure, respiratory failure, etc.)
- Patients who are planning to undergo deep brain stimulation within the study period
- Pregnant or lactating women
- Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less
- If there has been a change in the dosage of antiparkinsonian drugs (e.g., L-dopa, COMT (catechol-O-methyltransferase) inhibitor, Dopamine agonist, MAO-B (monoamine oxidase
- inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment
- Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapy for Parkinson's disease according to a doctor's prescription within the last 4 weeks prior to enrollment, or are planning to receive such therapy within the study period
- Patients who are not suitable for participation in this clinical study according to the judgment of the researcher