search
Back to results

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

Primary Purpose

Parkinson Disease, Physical Medicine, Rehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
Isokinetic reeducation
Conventional reeducation
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de MartiniqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Patient with conventional rehabilitation session and isokinetic reeducation during 7 weeks

Patient with conventional rehabilitation session during 7 weeks

Outcomes

Primary Outcome Measures

Patient posture
Measure in centimetres from the arrow to C7

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2020
Last Updated
February 8, 2023
Sponsor
University Hospital Center of Martinique
search

1. Study Identification

Unique Protocol Identification Number
NCT04492345
Brief Title
Assessment of a Special Modality of Back Muscles Strengthening for Postural Deformations in Parkinsonian Patient
Acronym
ISOPARK
Official Title
Impact of Isocinetism on the Disorders of the Spinal Statics of the Parkinsonian Patient
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Physical Medicine, Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patient with conventional rehabilitation session and isokinetic reeducation during 7 weeks
Arm Title
Control
Arm Type
Other
Arm Description
Patient with conventional rehabilitation session during 7 weeks
Intervention Type
Other
Intervention Name(s)
Isokinetic reeducation
Intervention Description
Conventional rehabilitation session and isokinetic during 7 weeks
Intervention Type
Other
Intervention Name(s)
Conventional reeducation
Intervention Description
Conventional rehabilitation session during 7 weeks
Primary Outcome Measure Information:
Title
Patient posture
Description
Measure in centimetres from the arrow to C7
Time Frame
After 8 weeks of reeducation
Secondary Outcome Measure Information:
Title
Spinal muscle strength
Description
Static contraction measured in holding time in seconds
Time Frame
After 8 weeks of reeducation
Title
Spinal muscle strength
Description
Isokinetic contraction measured by a force in Newton/Kg and an abdominal spinal ratio of 66%.
Time Frame
After 8 weeks of reeducation
Title
Improvement of balance
Description
Increasing the score on the BERG BALANCE SCALE BETWEEN 0 - 56.
Time Frame
After 8 weeks of reeducation
Title
Walking speed
Description
Carry out a 10-metre Walk Test
Time Frame
After 8 weeks of reeducation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia SABINE
Phone
+596596488056
Email
sophia.sabine@chu-martinique.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Corine CARPIN
Phone
+596596592696
Ext
3382
Email
corine.carpin@chu-martinique.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine SOPHIA
Organizational Affiliation
CHU Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Martinique
City
Le Lamentin
ZIP/Postal Code
97232
Country
Martinique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corine CARPIN
Phone
0596592696
Ext
3382
Email
corine.carpin@chu-martinique.fr
First Name & Middle Initial & Last Name & Degree
Sophia SABINE

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Tiffreau V, Preudhomme M, Defebvre L. Troubles de la statique au cours des affections neurologiques évolutives: syndromes parkinsoniens et pathologies musculaires. Revue du rhumatisme monographies 78 (2011) 26-31
Results Reference
background
PubMed Identifier
25552609
Citation
Hubble RP, Naughton GA, Silburn PA, Cole MH. Trunk muscle exercises as a means of improving postural stability in people with Parkinson's disease: a protocol for a randomised controlled trial. BMJ Open. 2014 Dec 31;4(12):e006095. doi: 10.1136/bmjopen-2014-006095.
Results Reference
background
Citation
Hutin E et al, Communications orales- Maladie de Parkinson. Effet d'une kinésithérapie standardisée sur la stabilité posturale dans la maladie de Parkinson au stade modéré. CO36-002-f. Annals of Physical and Rehabilitation Medicine 56S (2013) e190-e196.
Results Reference
background
PubMed Identifier
17016120
Citation
Crizzle AM, Newhouse IJ. Is physical exercise beneficial for persons with Parkinson's disease? Clin J Sport Med. 2006 Sep;16(5):422-5. doi: 10.1097/01.jsm.0000244612.55550.7d.
Results Reference
background
PubMed Identifier
25806509
Citation
Frazzitta G, Ferrazzoli D, Maestri R, Rovescala R, Guaglio G, Bera R, Volpe D, Pezzoli G. Differences in muscle strength in parkinsonian patients affected on the right and left side. PLoS One. 2015 Mar 25;10(3):e0121251. doi: 10.1371/journal.pone.0121251. eCollection 2015.
Results Reference
background
Citation
Edouard P, Degache F. Guide d'isocinétisme, L'évaluation isocinétique des concepts aux conditions sportives et pathologiques. Elsevier Masson;09/2016.
Results Reference
background
PubMed Identifier
29525296
Citation
Lannuzel A, Edragas R, Lackmy A, Tressieres B, Pelonde V, Kaptue MEN, Mecharles S, Demas A, Francois B, McGovern E, Vidailhet M, Gaymard B, Roze E. Further evidence for a distinctive atypical degenerative parkinsonism in the Caribbean: A new cluster in the French West Indian Island of Martinique. J Neurol Sci. 2018 May 15;388:214-219. doi: 10.1016/j.jns.2018.02.019. Epub 2018 Feb 6.
Results Reference
background
PubMed Identifier
25997862
Citation
DiFrancisco-Donoghue J, Jung MK, Geisel P, Werner WG. Learning effects of the sensory organization test as a measure of postural control and balance in Parkinson's disease. Parkinsonism Relat Disord. 2015 Aug;21(8):858-61. doi: 10.1016/j.parkreldis.2015.05.007. Epub 2015 May 14.
Results Reference
background
PubMed Identifier
27097000
Citation
Lima LO, Cardoso F, Teixeira-Salmela LF, Rodrigues-de-Paula F. Work and power reduced in L-dopa naive patients in the early-stages of Parkinson's disease. Arq Neuropsiquiatr. 2016 Apr;74(4):287-92. doi: 10.1590/0004-282X20160014.
Results Reference
background
PubMed Identifier
20435478
Citation
Durmus B, Baysal O, Altinayar S, Altay Z, Ersoy Y, Ozcan C. Lower extremity isokinetic muscle strength in patients with Parkinson's disease. J Clin Neurosci. 2010 Jul;17(7):893-6. doi: 10.1016/j.jocn.2009.11.014.
Results Reference
background
PubMed Identifier
25260231
Citation
Cano-de-la-Cuerda R, Vela-Desojo L, Miangolarra-Page JC, Macias-Macias Y. Isokinetic dynamometry as a technologic assessment tool for trunk rigidity in Parkinson's disease patients. NeuroRehabilitation. 2014;35(3):493-501. doi: 10.3233/NRE-141142.
Results Reference
background
PubMed Identifier
20138321
Citation
Gracies JM. [Neurorehabilitation in parkinsonian syndromes]. Rev Neurol (Paris). 2010 Feb;166(2):196-212. doi: 10.1016/j.neurol.2009.10.026. Epub 2010 Feb 6. French.
Results Reference
background
Citation
Tambosco L et al, Communications orales- Maladie de Parkinson. Particularités de la réponse à l'effort chez les patients atteints d'une maladie de Parkinson. CO36-003-f. Annals of Physical and Rehabilitation Medicine 56S (2013) e190-e196.
Results Reference
background
Links:
URL
https://www.elitemedicale.fr/media/documentations/Easytech/isocinetisme/Isocinetique_easytech_guide_clinique.pdf
Description
Isocinetique_easytech_guide_clinique.pdf

Learn more about this trial

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

We'll reach out to this number within 24 hrs