NCT04492345

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
1mo left

Started Jun 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2021Jun 2026

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 11, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4.8 years

First QC Date

April 21, 2020

Last Update Submit

February 12, 2024

Conditions

Parkinson DiseasePhysical MedicineRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Patient posture

    Measure in centimetres from the arrow to C7

    After 8 weeks of reeducation

Secondary Outcomes (4)

  • Spinal muscle strength

    After 8 weeks of reeducation

  • Spinal muscle strength

    After 8 weeks of reeducation

  • Improvement of balance

    After 8 weeks of reeducation

  • Walking speed

    After 8 weeks of reeducation

Study Arms (2)

Experimental

EXPERIMENTAL

Patient with conventional rehabilitation session and isokinetic reeducation during 7 weeks

Other: Isokinetic reeducation

Control

OTHER

Patient with conventional rehabilitation session during 7 weeks

Other: Conventional reeducation

Interventions

Isokinetic reeducationOTHER

Conventional rehabilitation session and isokinetic during 7 weeks

Experimental
Conventional reeducationOTHER

Conventional rehabilitation session during 7 weeks

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Martinique

Le Lamentin, 97232, Martinique

RECRUITING

Related Publications (13)

  • 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

    BACKGROUND

  • 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.

    PMID: 25552609BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 17016120BACKGROUND

  • 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.

    PMID: 25806509BACKGROUND

  • Edouard P, Degache F. Guide d'isocinétisme, L'évaluation isocinétique des concepts aux conditions sportives et pathologiques. Elsevier Masson;09/2016.

    BACKGROUND

  • 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.

    PMID: 29525296BACKGROUND

  • 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.

    PMID: 25997862BACKGROUND

  • 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.

    PMID: 27097000BACKGROUND

  • 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.

    PMID: 20435478BACKGROUND

  • 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.

    PMID: 25260231BACKGROUND

  • 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.

    PMID: 20138321BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sabine SOPHIA

    CHU Martinique

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia SABINE

CONTACT

+596596488056sophia.sabine@chu-martinique.fr

Corine CARPIN

CONTACT

+596596592696corine.carpin@chu-martinique.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

July 30, 2020

Study Start

June 11, 2021

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)