- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189680
Agility Training in Parkinson's Disease
A High-Intensity Multi-Component Agility Intervention Improves Parkinson's Patients' Clinical and Motor Symptoms
Study Overview
Detailed Description
Design: Intervention study
Setting: Outpatient rehabilitation center
Participants: 55 Parkinson's disease (PD) patients completed the trial and 42 serves as comparison healthy controls
Intervention: An initial screening established specific dysfunctions of PD patients with Hoehn-Yahr stage 2-3 who were then randomly assigned to standard care (n = 20) or standard care plus at-limit intensity, individualized agility program (15 sessions, 3 weeks, n = 35).
Main outcome measures: Movement Disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms
In group time, repeated measurements of variance analysis were compared to the picture parkinson's disease based on MDS-UPDRS M-EDL, Beck depression score, PDQ-39, EQ5D VAS, Schwab & England scale. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard.
An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demented, stage 2-3 PD patients' clinical symptoms, mobility, and postural stability by functionally meaningful margins.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Somogy
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Kaposvár, Somogy, Hungary, 7400
- Somogy Megyei Kaposi Mór Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parkinson's disease
- Hoenh Yahr scale of 2-3
- Instability problem
Exclusion Criteria:
- Severe heart problems
- Severe demeanor
- Alcoholism
- Drug problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise therapy
Parkinson's disease group that receive 3 weeks of intensive exercise therapy in a rehabilitation center.
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3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training
Other Names:
|
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NO_INTERVENTION: Control
Parkinson's disease control group that will not receive exercise treatment.
|
|
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NO_INTERVENTION: Healthy
A healthy group whose results will be compared with Parkinson's disease groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EQ5D-5L
Time Frame: 0-5 scale (3 week-long, higher number is better)
|
Questionnaire
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0-5 scale (3 week-long, higher number is better)
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
- IKEB0012/2015
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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