Clinical trial NCT02797496: Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease.
Official title: Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Mild to moderate stage
Asymmetric Motor Strengthening
Rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
timeFrame: Baseline (D1) and Day 60
Secondary outcomes:
measure: UPDRS III score in " ON " medication state
timeFrame: Baseline (Day 1), Day 60 and Day 150
measure: UPDRS III score in " OFF " medication state
timeFrame: Day 150
measure: 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
timeFrame: Day 1, Day 60 and Day 150
measure: Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150
timeFrame: Day 1, Day 60 and Day 150
measure: Kinematic measurements of trunk inclination
timeFrame: Day 1 and Day 60
measure: Balance measurement on posturography
timeFrame: Day 1 and Day 60
measure: Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)
timeFrame: Day 1, Day 60 and Day 150
measure: Mount Sinai Parkinson Impairment Rating Scale
timeFrame: Day 1, Day 60 and Day 150
measure: Global Mobility Task (GMT)
timeFrame: Day 1, Day 60 and Day 150
measure: Geriatric Depression Scale - 15 items
timeFrame: Day 1, Day 60 and Day 150
measure: Quality of life measured by PDQ-39
timeFrame: Day 1, Day 60 and Day 150
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Michel GRACIES, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: