- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522138
Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study (SelfExPD)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Won-Seok Kim, MD, PhD
- Phone Number: +82317877735
- Email: wondol77@gmail.com
Study Contact Backup
- Name: SunJeong Gwon, BS
- Phone Number: +8210-2836-5937
- Email: otchoice@daum.net
Study Locations
-
-
-
Seongnam-si, South Korea, 13620
- Seoul National University Bundang Hospital
-
Contact:
- Won-Seok Kim, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 19 years or older, clinically diagnosed with Idiopathic Parkinson's Disease (PD) according to the Movement Disorder Society (MDS) clinical diagnostic criteria
- Patients at Hoehn and Yahr stage 1-2.5
- Patients on stable dopaminergic therapy with no changes in the past 1 month
- Patients receiving Lee Silverman Voice Treatment (LSVT) rehabilitation therapy once weekly as outpatients
- Patients who have voluntarily provided informed consent to participate in the study
Exclusion Criteria:
- Patients diagnosed with atypical parkinsonism
- Patients with musculoskeletal problems that make participation in rehabilitation difficult
- Patients who have limited access to the video-based home exercise feedback program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home-based Exercise Program (Single Arm)
Participants follow a 6-week home-based exercise program guided by instructional videos, including stretching, strength, balance, aerobic, and LSVT-specific exercises.
A camera provides real-time feedback using the iPixel exercise feedback system, and participants complete sessions at least 5 times per week, 40 minutes per session, with weekly 30-minute in-person check-ins for monitoring and support.
|
Participants follow a 6-week home-based exercise program using video-guided instructions and the iPixel exercise feedback system, which monitors movements in real-time and provides corrective feedback. The program includes: Stretching exercises, Strength training, Balance exercises, Aerobic exercises, LSVT-specific exercises. Participants are instructed to complete sessions at least 5 times per week, 40 minutes per session. Additionally, weekly 30-minute in-person rehabilitation sessions are conducted to adjust the next week's exercise intensity based on each participant's functional level. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III (Motor Examination)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
0 to 108, with higher scores indicating worse motor function.
|
From enrollment to the end of treatment at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Hoehn and Yahr sacle
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Modified Hoehn and Yahr Scale Score range: 0 to 5, with higher scores indicating more severe disease stage.
|
From enrollment to the end of treatment at 6 weeks
|
|
Berg Balance Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
|
0 to 56, with higher scores indicating better balance ability.
|
From enrollment to the end of treatment at 6 weeks
|
|
Functional Gait Ability
Time Frame: From enrollment to the end of treatment at 6 weeks
|
0 to 30, with higher scores indicating better gait function.
|
From enrollment to the end of treatment at 6 weeks
|
|
Freezing of Gait Questionnaire
Time Frame: From enrollment to the end of treatment at 6 weeks
|
0 to 24, with higher scores indicating more severe freezing of gait.
|
From enrollment to the end of treatment at 6 weeks
|
|
EuroQol-5 Dimention Questionnaire
Time Frame: From enrollment to the end of treatment at 6 weeks
|
0 to 1, with higher scores indicating better health-related quality of life.
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Won-Seok Kim, MD, PhD, Seoul National University Bundang Hospital
Publications and helpful links
General Publications
- Colon-Semenza C, Latham NK, Quintiliani LM, Ellis TD. Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study. JMIR Mhealth Uhealth. 2018 Feb 15;6(2):e42. doi: 10.2196/mhealth.8074.
- van Nimwegen M, Speelman AD, Hofman-van Rossum EJ, Overeem S, Deeg DJ, Borm GF, van der Horst MH, Bloem BR, Munneke M. Physical inactivity in Parkinson's disease. J Neurol. 2011 Dec;258(12):2214-21. doi: 10.1007/s00415-011-6097-7. Epub 2011 May 26.
- Politis M, Wu K, Molloy S, G Bain P, Chaudhuri KR, Piccini P. Parkinson's disease symptoms: the patient's perspective. Mov Disord. 2010 Aug 15;25(11):1646-51. doi: 10.1002/mds.23135.
- Fox SH, Luca DG, Postuma RB, Bhidayasiri R, Cardoso F, Kovacs GG, Katzenschlager R, Trenkwalder C. Revisiting the 2015 MDS diagnostic criteria for Parkinson disease: insights from autopsy-confirmed cases. NPJ Parkinsons Dis. 2025 Dec 13;11(1):360. doi: 10.1038/s41531-025-01206-6.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2602-1027-304 (Other Identifier: Seoul National University Bundang Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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