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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (Meridian Activation Remedy System for Parkinson's Disease) | Experimental | Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week) |
|
| Control group (Usual Care) | No Intervention | Usual care (all participants will be allowed to continue their prescribed medication and treatment (except Korean Medicine therapy), and they will not receive any additional treatment or therapy in the research institute), and lifestyle advice (all participants will receive a smart band and application-based guidance about their lifestyle) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) | Other | MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part â…¢ | MDS-UPDRS Part â…¢ (maximum: 132, minimum: 0; higher scores mean a worse outcome) | Change from baseline MDS-UPDRS Part â…¢ score at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part â…¢ | MDS-UPDRS Part â…¢ | Change from baseline MDS-UPDRS Part â…¢ score at 4 and 12 weeks |
| International Physical Activity Questionnaire Short Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho Ryong Yoo, Prof. Dr. | Daejeon University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University | Daejeon | 35235 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41641966 | Derived | Hur WJ, Seo JW, Park MS, Yoo HR. Visual self-reporting for symptom communication in Parkinson's disease. Technol Health Care. 2026 Mar;34(2):287-299. doi: 10.1177/09287329251414326. Epub 2026 Feb 5. | |
| 38709746 | Derived | Park MS, Park S, Kang JY, Jung IC, Yoo H. The efficacy and safety of MARS-PD: Meridian activation remedy system for Parkinson's disease-A single-center, assessor and statistician-blinded, parallel-group randomized, controlled trial protocol. PLoS One. 2024 May 6;19(5):e0303156. doi: 10.1371/journal.pone.0303156. eCollection 2024. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
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IPAQ
| Change from baseline IPAQ score at 4, 8 and 12 weeks |
| Parkinson Self Questionnaire | Parkinson Self Questionnaire, developed by researchers | Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks |
| Parkinson's disease Sleep Scale | PDSS | Change from baseline PDSS score at 4, 8 and 12 weeks |
| Timed up and go test | TUG | Change from baseline TUG time in seconds at 8 and 12 weeks |
| GAITRite Electronic Walkway Platinum | GAITRite | Change from baseline GAITRite parameters at 8 and 12 weeks |
| Functional near-infrared spectroscopy | fNIRS | Change from baseline fNIRS results at 8 and 12 weeks |
| Smart band outcomes | Number of steps per day | Change from baseline daily steps at 4, 8 and 12 weeks |
| Iris imaging 1 | Visible light image | Iris connective tissue texture, baseline |
| Iris imaging 2 | Infrared image | Iris connective tissue density, baseline |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale | MDS-UPDRS | Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks |
| Gut microbiome test | Gut microbiome diversity and composition, fecal samples | Change from baseline gut microbiome analysis results at 8 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |