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

NCT ID: NCT02797496

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Asymmetric Motor Strengthening

Group Type: EXPERIMENTAL

Asymmetric Motor Strengthening

Intervention Type: 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.

Conventional Therapy

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Conventional therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel GRACIES, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Henri Mondor Hospital

Créteil, , France

Countries

France

Other Identifiers

2009-A00669-48

Identifier Type: OTHER

Identifier Source: secondary_id

P071236

Identifier Type: -

Identifier Source: org_study_id