- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442370
The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients
The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
-
-
Sancaktepe
-
Istanbul, Sancaktepe, Turkey (Türkiye)
- Recruiting
- Sancak Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Individuals with a clinical diagnosis of idiopathic Parkinson's disease (Hoehn & Yahr stages 1-2)
- Individuals aged 50-70 years
- Mini Mental State Test score ≥ 24
- Individuals whose medical treatment has been stable in the last 6 weeks
- Individuals with stable vital signs
- Individuals who volunteer to participate in the study and understand the purpose and process of the study, and who have signed a written informed consent form
Exclusion Criteria
- Advanced Parkinson's disease (H&Y 3-5)
- Severe orthopedic problems
- Vestibular system disorders
- History of serious falls in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
only patients who will receive a conventional physiotherapy program
|
Conventional physiotherapy will be applied for 6 weeks, with 3 sessions per week, each session lasting approximately 40-50 minutes. Participants will be given stretching and flexibility exercises (trunk, shoulder and lower extremity muscle groups) in each session, with 10 repetitions x 15 seconds. Balance exercises (3 repetitions for 30-45 seconds in static and dynamic balance positions), walking exercises on a flat surface, and strengthening exercises (2-3 sets, 10-12 repetitions with resistance band or dumbbells) will be performed. |
|
Experimental: exercise group
Patients who will receive a special exercise program in addition to a conventional physiotherapy program.
|
Conventional physiotherapy will be applied for 6 weeks, with 3 sessions per week, each session lasting approximately 40-50 minutes. Participants will be given stretching and flexibility exercises (trunk, shoulder and lower extremity muscle groups) in each session, with 10 repetitions x 15 seconds. Balance exercises (3 repetitions for 30-45 seconds in static and dynamic balance positions), walking exercises on a flat surface, and strengthening exercises (2-3 sets, 10-12 repetitions with resistance band or dumbbells) will be performed.
This group will receive conventional physical therapy and functional rotation exercises for 6 weeks, with 3 sessions per week, each session lasting approximately 40-50 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: 10 weeks
|
This outcome measure will be used to assess functional mobility using a virtual reality-based adaptation of the Timed Up and Go test.
Test completion time will be automatically recorded by the system.
Validity and reliability will be examined through comparison with the conventional Timed Up and Go test and repeated measurements.
|
10 weeks
|
|
Berg Balance Test
Time Frame: 10 weeks
|
Berg Balance Test is consisting of 14 items and measures the ability of individuals to maintain balance while performing functional tasks.
Each task is scored from 0 (cannot perform independently) to 4 (stated best performance).
0-20 points are interpreted as high risk of falling, between 21-40 points as medium risk of falling, and between 41-56 points as low risk.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kübra UZUN, Uskudar University
Publications and helpful links
General Publications
- Bellows S. Physiotherapy and Exercise in Parkinson's Disease. Neurol Clin. 2025 May;43(2):427-443. doi: 10.1016/j.ncl.2024.12.014. Epub 2025 Jan 24.
- Zhang J, Wu M, Hou X, Song W, Li J, Teng L, Li X, Yu D, Pan J, Zhu L. Unconventional exercises for motor function in Parkinson's disease: an umbrella review of meta-analyses. Age Ageing. 2025 Mar 3;54(3):afaf062. doi: 10.1093/ageing/afaf062.
- Jansen JA, Buurke TJ, van de Venis L, Weerdesteyn V, Keijsers N, Nonnekes J. Narrow-based gait in people with Parkinson's disease: Its mechanisms explored. J Parkinsons Dis. 2025 Mar;15(2):329-337. doi: 10.1177/1877718X241313333. Epub 2025 Feb 2.
Study record dates
Study Major Dates
Study Start (Actual)
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
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Parkinsonian Disorders
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- Uskudar91
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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