AzTrials
AzTrials

Parkinson DiseaseISOPARKNCT04492345

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

A study testing Isokinetic reeducation and Conventional reeducation in people with Parkinson Disease and Physical Medicine, run by University Hospital Center of Martinique at 1 site in Martinique.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Isokinetic reeducation and Conventional reeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMartinique
Study dates
11 Jun 2021to Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sophia SABINE contact

+596596488056

sophia.sabine@chu-martinique.fr

Corine CARPIN contact

+596596592696 ext. 3382

corine.carpin@chu-martinique.fr

Martinique1 site, 1 recruiting

  • CHU de Martinique

    Le Lamentin, 97232

    Corine CARPIN, 0596592696 ext. 3382, corine.carpin@chu-martinique.fr

    Sophia SABINE

    Recruiting

Other trials in Martinique

About this study

Official title: 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.

Read the 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.

Being tested
Isokinetic reeducation, Conventional reeducation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isokinetic reeducationOther

    Conventional rehabilitation session and isokinetic during 7 weeks

  • Conventional reeducationOther

    Conventional rehabilitation session during 7 weeks

Study groups in NCT04492345
Study groupRoleWhat they receive
ExperimentalExperimentalPatient with conventional rehabilitation session and isokinetic reeducation during 7 weeks
Receives: Other: Isokinetic reeducation
ControlOtherPatient with conventional rehabilitation session during 7 weeks
Receives: Other: Conventional reeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient posture

    Measure in centimetres from the arrow to C7

    Measured: After 8 weeks of reeducation

Secondary outcomes (4)

  1. Spinal muscle strength

    Static contraction measured in holding time in seconds

    Measured: After 8 weeks of reeducation

  2. Spinal muscle strength

    Isokinetic contraction measured by a force in Newton/Kg and an abdominal spinal ratio of 66%.

    Measured: After 8 weeks of reeducation

  3. Improvement of balance

    Increasing the score on the BERG BALANCE SCALE BETWEEN 0 - 56.

    Measured: After 8 weeks of reeducation

  4. Walking speed

    Carry out a 10-metre Walk Test

    Measured: After 8 weeks of reeducation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start11 Jun 2021
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04492345
Sponsor's protocol ID
18_RIPH2-10
Acronym
ISOPARK
Status last verified
Feb 2024
First submitted
21 Apr 2020
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 25552609

  • 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.

  • 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.

    PubMed 17016120

  • 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.

    PubMed 25806509

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

  • 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.

    PubMed 29525296

  • 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.

    PubMed 25997862

  • 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.

    PubMed 27097000

  • 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.

    PubMed 20435478

  • 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.

    PubMed 25260231

  • 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.

    PubMed 20138321

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Isokinetic reeducation and Conventional reeducation in people with Parkinson Disease and Physical Medicine, run by University Hospital Center of Martinique at 1 site in Martinique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sophia SABINE (+596596488056, sophia.sabine@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient posture (time frame: After 8 weeks of reeducation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04492345, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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