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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Conventional therapy; Other: Asymmetric Motor Strengthening

• Registration Number: NCT02797496
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2014-02
• Study Completion: 2014-06
• Status Verified: 2016-01
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-08
• Last Update Submitted: 2016-06-08
• Study First Posted: 2016-06-13
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Therapy	Conventional therapy	-
Asymmetric Motor Strengthening	Asymmetric Motor Strengthening	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Créteil, France