Assessment of a Special Modality of Back Muscles Strengthening for Postural Deformations in Parkinsonian Patient (ISOPARK)

February 12, 2024 updated by: University Hospital Center of Martinique

Impact of Isocinetism on the Disorders of the Spinal Statics of the Parkinsonian Patient

Parkinson's patients have postural disorders. These disorders are frequent in Martinique. Physiotherapeutic rehabilitation is essential because these disorders are generally non dopa-sensitive.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postural disorders are very common in Martinique, in patients often having an atypical form of the Parkinson's disease. Physiotherapy rehabilitation is essential because these disorders are generally non-dopa-sensitive. Isokinetic muscle strength may reduce postural disorder in Parkinson's disease.

Isokinetic device rehabilitation promotes maximum muscular contraction at constant speed; the resistance of the machine continuously adapting to the force developed by the subject. As the spinal muscle strength gain is superior to conventional post-rehabilitation motor function, the improvement in postural instability should be greater than that achieved with conventional rehabilitation. A better postural support should thus result in a decrease in the risk of falling and an improvement in the quality of walking.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with Parkinson's disease or atypical parkinsonian syndrome
  • Age ≥18 years
  • Patient with postural disorders with a cervical arrow> 6cm in the sagittal plane and / or the axis C7S2 different from 0 in the frontal plane
  • UPDRS between 10 and 25/108.
  • Antiparkinsonian treatment stabilized for 8 weeks
  • MMS test> 25
  • Insured person or beneficiary of social security

Exclusion Criteria:

  • Patient with a neurological condition other than parkinsonian syndrome
  • Patient with rheumatic disease
  • Patient with a history of trunk surgery
  • Patient with a brain stimulator
  • Cardiac pathology not stabilized
  • Incapacitated adult, or under guardianship, or under curatorship or under judicial protection curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Patient with conventional rehabilitation session and isokinetic reeducation during 7 weeks
Other: Isokinetic reeducation
Conventional rehabilitation session and isokinetic during 7 weeks
Other: Control
Patient with conventional rehabilitation session during 7 weeks
Other: Conventional reeducation
Conventional rehabilitation session during 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient posture
Time Frame: After 8 weeks of reeducation
Measure in centimetres from the arrow to C7
After 8 weeks of reeducation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal muscle strength
Time Frame: After 8 weeks of reeducation
Static contraction measured in holding time in seconds
After 8 weeks of reeducation
Spinal muscle strength
Time Frame: After 8 weeks of reeducation
Isokinetic contraction measured by a force in Newton/Kg and an abdominal spinal ratio of 66%.
After 8 weeks of reeducation
Improvement of balance
Time Frame: After 8 weeks of reeducation
Increasing the score on the BERG BALANCE SCALE BETWEEN 0 - 56.
After 8 weeks of reeducation
Walking speed
Time Frame: After 8 weeks of reeducation
Carry out a 10-metre Walk Test
After 8 weeks of reeducation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Center of Martinique

Investigators

  • Principal Investigator: Sabine SOPHIA, CHU Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18_RIPH2-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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