Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University
Daejeon, 35235, South Korea
NCT Number: NCT05621772
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.
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Notify Me45 year–75 year
All sexes
Interventional
Not applicable
Daejeon, 35235, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.
Time frame: 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)
Time frame: Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks
MDS-UPDRS Part Ⅲ
Time frame: Change from baseline IPAQ score at 4, 8 and 12 weeks
IPAQ
Time frame: Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks
Parkinson Self Questionnaire, developed by researchers
Time frame: Change from baseline PDSS score at 4, 8 and 12 weeks
PDSS
Time frame: Change from baseline TUG time in seconds at 8 and 12 weeks
TUG
Time frame: Change from baseline GAITRite parameters at 8 and 12 weeks
GAITRite
Time frame: Change from baseline fNIRS results at 8 and 12 weeks
fNIRS
Time frame: Change from baseline daily steps at 4, 8 and 12 weeks
Number of steps per day
Time frame: Iris connective tissue texture, baseline
Visible light image
Time frame: Iris connective tissue density, baseline
Infrared image
Time frame: Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks
MDS-UPDRS
Time frame: Change from baseline gut microbiome analysis results at 8 weeks
Gut microbiome diversity and composition, fecal samples
Korea Health Industry Development Institute
Other Gov
MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Acronym: MARS-PD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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