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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04492345
Other study ID # 18_RIPH2-10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 11, 2021
Est. completion date June 2026

Study information

Verified date February 2024
Source University Hospital Center of Martinique
Contact Sophia SABINE
Phone +596596488056
Email sophia.sabine@chu-martinique.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Isokinetic reeducation
Conventional rehabilitation session and isokinetic during 7 weeks
Conventional reeducation
Conventional rehabilitation session during 7 weeks

Locations

Country Name City State
Martinique CHU de Martinique Le Lamentin

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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.

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. — View 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. — View 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.

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

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Patient posture Measure in centimetres from the arrow to C7 After 8 weeks of reeducation
Secondary Spinal muscle strength Static contraction measured in holding time in seconds After 8 weeks of reeducation
Secondary Spinal muscle strength Isokinetic contraction measured by a force in Newton/Kg and an abdominal spinal ratio of 66%. After 8 weeks of reeducation
Secondary Improvement of balance Increasing the score on the BERG BALANCE SCALE BETWEEN 0 - 56. After 8 weeks of reeducation
Secondary Walking speed Carry out a 10-metre Walk Test After 8 weeks of reeducation
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