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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Asymmetric Motor Strengthening
Conventional therapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Mild to moderate stage, Asymmetric Motor Strengthening, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asymmetric Motor Strengthening

Conventional Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60

Secondary Outcome Measures

UPDRS III score in " ON " medication state
UPDRS III score in " OFF " medication state
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
Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150
Kinematic measurements of trunk inclination
Balance measurement on posturography
Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)
Mount Sinai Parkinson Impairment Rating Scale
Global Mobility Task (GMT)
Geriatric Depression Scale - 15 items
Quality of life measured by PDQ-39

Full Information

First Posted
June 8, 2016
Last Updated
June 8, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02797496
Brief Title
Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease.
Acronym
ASYMOT
Official Title
Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Mild to moderate stage, Asymmetric Motor Strengthening, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asymmetric Motor Strengthening
Arm Type
Experimental
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Asymmetric Motor Strengthening
Intervention Description
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
Intervention Name(s)
Conventional therapy
Intervention Description
Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
UPDRS III score in " ON " medication state
Time Frame
Baseline (Day 1), Day 60 and Day 150
Title
UPDRS III score in " OFF " medication state
Time Frame
Day 150
Title
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
Title
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
Title
Kinematic measurements of trunk inclination
Time Frame
Day 1 and Day 60
Title
Balance measurement on posturography
Time Frame
Day 1 and Day 60
Title
Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)
Time Frame
Day 1, Day 60 and Day 150
Title
Mount Sinai Parkinson Impairment Rating Scale
Time Frame
Day 1, Day 60 and Day 150
Title
Global Mobility Task (GMT)
Time Frame
Day 1, Day 60 and Day 150
Title
Geriatric Depression Scale - 15 items
Time Frame
Day 1, Day 60 and Day 150
Title
Quality of life measured by PDQ-39
Time Frame
Day 1, Day 60 and Day 150

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel GRACIES, Md, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Créteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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