Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
Time Frame: Baseline (D1) and Day 60
Secondary Outcomes
- UPDRS III score in " ON " medication state(Baseline (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)
- Balance measurement on posturography(Day 1 and Day 60)
- 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)
- Global Mobility Task (GMT)(Day 1, Day 60 and Day 150)
- Kinematic measurements of trunk inclination(Day 1 and Day 60)
- Quality of life measured by PDQ-39(Day 1, Day 60 and Day 150)
- 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)
- Geriatric Depression Scale - 15 items(Day 1, Day 60 and Day 150)