Parkinson Disease
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERMeridian Activation Remedy System for Parkinson's Disease (MARS-PD)
MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.
Sponsors
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 45 to 75 years of age 2. Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria 3. Hoehn and Yahr scale stage I to III 4. Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form
Exclusion criteria
1. 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.) 2. Patients who are planning to undergo deep brain stimulation within the study period 3. Pregnant or lactating women 4. Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less 5. 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 B) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment 6. 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 7. Patients who are not suitable for participation in this clinical study according to the judgment of the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ | Change from baseline MDS-UPDRS Part Ⅲ score at 8 weeks | MDS-UPDRS Part Ⅲ (maximum: 132, minimum: 0; higher scores mean a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Physical Activity Questionnaire Short Form | Change from baseline IPAQ score at 4, 8 and 12 weeks | IPAQ |
| Parkinson Self Questionnaire | Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks | Parkinson Self Questionnaire, developed by researchers |
| Parkinson's disease Sleep Scale | Change from baseline PDSS score at 4, 8 and 12 weeks | PDSS |
| Timed up and go test | Change from baseline TUG time in seconds at 8 and 12 weeks | TUG |
| GAITRite Electronic Walkway Platinum | Change from baseline GAITRite parameters at 8 and 12 weeks | GAITRite |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ | Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks | MDS-UPDRS Part Ⅲ |
| Smart band outcomes | Change from baseline daily steps at 4, 8 and 12 weeks | Number of steps per day |
| Iris imaging 1 | Iris connective tissue texture, baseline | Visible light image |
| Iris imaging 2 | Iris connective tissue density, baseline | Infrared image |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale | Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks | MDS-UPDRS |
| Gut microbiome test | Change from baseline gut microbiome analysis results at 8 weeks | Gut microbiome diversity and composition, fecal samples |
| Functional near-infrared spectroscopy | Change from baseline fNIRS results at 8 and 12 weeks | fNIRS |
Countries
South Korea
Outcome results
None listed