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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02797496
Acronym
ASYMOT
Enrollment
39
Registered
2016-06-13
Start date
2010-12-31
Completion date
2014-06-30
Last updated
2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

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

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.

Interventions

OTHERAsymmetric 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.

OTHERConventional therapy

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
UPDRS III score in OFF medication stateDay 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 stateDay 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 150Day 1, Day 60 and Day 150
Kinematic measurements of trunk inclinationDay 1 and Day 60
Balance measurement on posturographyDay 1 and Day 60
UPDRS III score in ON medication stateBaseline (Day 1), Day 60 and Day 150
Mount Sinai Parkinson Impairment Rating ScaleDay 1, Day 60 and Day 150
Global Mobility Task (GMT)Day 1, Day 60 and Day 150
Geriatric Depression Scale - 15 itemsDay 1, Day 60 and Day 150
Quality of life measured by PDQ-39Day 1, Day 60 and Day 150
Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)Day 1, Day 60 and Day 150

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026