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

NCT02797496 | Completed DMC

• 2 other identifiers: P0712362009-A00669-48
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Mild to moderate stage; Asymmetric Motor Strengthening; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

Asymmetric Motor Strengthening

EXPERIMENTAL

Other: Asymmetric Motor Strengthening

Conventional Therapy

ACTIVE COMPARATOR

Other: Conventional therapy

Interventions

Asymmetric Motor Strengthening OTHER

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.

Asymmetric Motor Strengthening

Conventional therapy OTHER

Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jean-Michel GRACIES, Md, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: December 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 13, 2016

Record last verified: 2016-01

Locations

FR (1)