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

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ClinicalTrials.gov Identifier: NCT02797496
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Asymmetric Motor Strengthening Other: Conventional therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
Study Start Date : December 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
Active Comparator: Conventional Therapy Other: Conventional therapy
Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.


Outcome Measures
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Primary Outcome Measures :
  1. Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60 [ Time Frame: Baseline (D1) and Day 60 ]

Secondary Outcome Measures :
  1. UPDRS III score in " ON " medication state [ Time Frame: Baseline (Day 1), Day 60 and Day 150 ]
  2. UPDRS III score in " OFF " medication state [ Time Frame: Day 150 ]
  3. 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 [ Time Frame: Day 1, Day 60 and Day 150 ]
  4. Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150 [ Time Frame: Day 1, Day 60 and Day 150 ]
  5. Kinematic measurements of trunk inclination [ Time Frame: Day 1 and Day 60 ]
  6. Balance measurement on posturography [ Time Frame: Day 1 and Day 60 ]
  7. Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper) [ Time Frame: Day 1, Day 60 and Day 150 ]
  8. Mount Sinai Parkinson Impairment Rating Scale [ Time Frame: Day 1, Day 60 and Day 150 ]
  9. Global Mobility Task (GMT) [ Time Frame: Day 1, Day 60 and Day 150 ]
  10. Geriatric Depression Scale - 15 items [ Time Frame: Day 1, Day 60 and Day 150 ]
  11. Quality of life measured by PDQ-39 [ Time Frame: Day 1, Day 60 and Day 150 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797496


Locations
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France
Henri Mondor Hospital
Créteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Michel GRACIES, Md, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02797496    
Other Study ID Numbers: P071236
2009-A00669-48 ( Other Identifier: ID RCB )
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson's disease
Mild to moderate stage
Asymmetric Motor Strengthening
Rehabilitation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases