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Completed

NCT Number: NCT02797496

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Conventional Therapy

Other

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

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

    Time frame: Baseline (D1) and Day 60

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ASYMOT

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2016
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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