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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Asymmetric Motor Strengthening; Other: Conventional therapy

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Therapy	Other: Conventional therapy; Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.
EXPERIMENTAL: Asymmetric Motor Strengthening	Other: Asymmetric Motor Strengthening; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (ESTIMATE): June 13, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Parkinson's disease; Mild to moderate stage; Asymmetric Motor Strengthening
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P071236; 2009-A00669-48 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED