Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease.

Study Overview
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Brief Summary
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Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years. The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease. There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease. This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects). The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.

Official Title
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Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Asymmetric Motor Strengthening
* Other: Conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient diagnosed with Parkinson's disease on UKPDSBB criteria. Hoehn & Yahr stage 2, 3 in OFF state Age ≥18 years Patient who agreed to sign an informed consent to participate in this study. Exclusion Criteria Patients who cannot or do not wish to follow a motor rehabilitation program for two months with a subsequent follow-up 3 months Intercurrent severe condition jeopardizing the vital or functional prognosis or the ability to participate in rehabilitation sessions. Cognitive dysfunction making effective communication or participation in a rehabilitation program impossible Person not benefiting from French State Health Insurance Current participation in another research protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asymmetric Motor Strengthening<br> | Other: Asymmetric Motor Strengthening<br>* In the Asymmetric Motor Strengthening program, the principle is to concomitantly reinforce the body openers and stretch the body closers. One alternates two types of practice during a session. Active exercises consist of fatiguing series of rapid alternating movements against light weights working on movements of extension/abduction/external rotation/supination. Stretch postures consists of short 1-2 minutes bouts of flexor/internal rotator/adductor/pronator stretch. The duration of rehabilitation program is 8 weeks.<br>|
| Active Comparator: Conventional Therapy<br> | Other: Conventional therapy<br>* Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the  OFF  medication state, between baseline (D1) and Day 60 |  | Baseline (D1) and Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS III score in  ON  medication state |  | Baseline (Day 1), Day 60 and Day 150 | 
| UPDRS III score in  OFF  medication state |  | Day 150 | 
| Speed and step length over 20 meters (with 2 turn around, 2 Stand up-Sit down and 2 Sit down-Stand up) at maximal speed in  OFF  medication state |  | Day 1, Day 60 and Day 150 | 
| Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150 |  | Day 1, Day 60 and Day 150 | 
| Kinematic measurements of trunk inclination |  | Day 1 and Day 60 | 
| Balance measurement on posturography |  | Day 1 and Day 60 | 
| Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper) |  | Day 1, Day 60 and Day 150 | 
| Mount Sinai Parkinson Impairment Rating Scale |  | Day 1, Day 60 and Day 150 | 
| Global Mobility Task (GMT) |  | Day 1, Day 60 and Day 150 | 
| Geriatric Depression Scale - 15 items |  | Day 1, Day 60 and Day 150 | 
| Quality of life measured by PDQ-39 |  | Day 1, Day 60 and Day 150 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Mild to moderate stage, Asymmetric Motor Strengthening, Rehabilitation