<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04492345</url>
  </required_header>
  <id_info>
    <org_study_id>18_RIPH2-10</org_study_id>
    <nct_id>NCT04492345</nct_id>
  </id_info>
  <brief_title>Assessment of a Special Modality of Back Muscles Strengthening for Postural Deformations in Parkinsonian Patient</brief_title>
  <acronym>ISOPARK</acronym>
  <official_title>Impact of Isocinetism on the Disorders of the Spinal Statics of the Parkinsonian Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's patients have postural disorders. These disorders are frequent in Martinique.&#xD;
      Physiotherapeutic rehabilitation is essential because these disorders are generally non&#xD;
      dopa-sensitive.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postural disorders are very common in Martinique, in patients often having an atypical form&#xD;
      of the Parkinson's disease. Physiotherapy rehabilitation is essential because these disorders&#xD;
      are generally non-dopa-sensitive. Isokinetic muscle strength may reduce postural disorder in&#xD;
      Parkinson's disease.&#xD;
&#xD;
      Isokinetic device rehabilitation promotes maximum muscular contraction at constant speed; the&#xD;
      resistance of the machine continuously adapting to the force developed by the subject. As the&#xD;
      spinal muscle strength gain is superior to conventional post-rehabilitation motor function,&#xD;
      the improvement in postural instability should be greater than that achieved with&#xD;
      conventional rehabilitation. A better postural support should thus result in a decrease in&#xD;
      the risk of falling and an improvement in the quality of walking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2021</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient posture</measure>
    <time_frame>After 8 weeks of reeducation</time_frame>
    <description>Measure in centimetres from the arrow to C7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spinal muscle strength</measure>
    <time_frame>After 8 weeks of reeducation</time_frame>
    <description>Static contraction measured in holding time in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal muscle strength</measure>
    <time_frame>After 8 weeks of reeducation</time_frame>
    <description>Isokinetic contraction measured by a force in Newton/Kg and an abdominal spinal ratio of 66%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of balance</measure>
    <time_frame>After 8 weeks of reeducation</time_frame>
    <description>Increasing the score on the BERG BALANCE SCALE BETWEEN 0 - 56.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>After 8 weeks of reeducation</time_frame>
    <description>Carry out a 10-metre Walk Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Physical Medicine</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with conventional rehabilitation session and isokinetic reeducation during 7 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient with conventional rehabilitation session during 7 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isokinetic reeducation</intervention_name>
    <description>Conventional rehabilitation session and isokinetic during 7 weeks</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional reeducation</intervention_name>
    <description>Conventional rehabilitation session during 7 weeks</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with Parkinson's disease or atypical parkinsonian syndrome&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Patient with postural disorders with a cervical arrow&gt; 6cm in the sagittal plane and /&#xD;
             or the axis C7S2 different from 0 in the frontal plane&#xD;
&#xD;
          -  UPDRS between 10 and 25/108.&#xD;
&#xD;
          -  Antiparkinsonian treatment stabilized for 8 weeks&#xD;
&#xD;
          -  MMS test&gt; 25&#xD;
&#xD;
          -  Insured person or beneficiary of social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a neurological condition other than parkinsonian syndrome&#xD;
&#xD;
          -  Patient with rheumatic disease&#xD;
&#xD;
          -  Patient with a history of trunk surgery&#xD;
&#xD;
          -  Patient with a brain stimulator&#xD;
&#xD;
          -  Cardiac pathology not stabilized&#xD;
&#xD;
          -  Incapacitated adult, or under guardianship, or under curatorship or under judicial&#xD;
             protection curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine SOPHIA</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Martinique</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophia SABINE</last_name>
    <phone>+596596488056</phone>
    <email>sophia.sabine@chu-martinique.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Corine CARPIN</last_name>
    <phone>+596596592696</phone>
    <phone_ext>3382</phone_ext>
    <email>corine.carpin@chu-martinique.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Le Lamentin</city>
        <zip>97232</zip>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corine CARPIN</last_name>
      <phone>0596592696</phone>
      <phone_ext>3382</phone_ext>
      <email>corine.carpin@chu-martinique.fr</email>
    </contact>
    <investigator>
      <last_name>Sophia SABINE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <link>
    <url>https://www.elitemedicale.fr/media/documentations/Easytech/isocinetisme/Isocinetique_easytech_guide_clinique.pdf</url>
    <description>Isocinetique_easytech_guide_clinique.pdf</description>
  </link>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25552609</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17016120</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25806509</PMID>
  </reference>
  <reference>
    <citation>Edouard P, Degache F. Guide d'isocinétisme, L'évaluation isocinétique des concepts aux conditions sportives et pathologiques. Elsevier Masson;09/2016.</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29525296</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25997862</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27097000</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20435478</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25260231</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20138321</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>April 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04492345
org study id: 18_RIPH2-10
nct id: NCT04492345
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parkinson's patients have postural disorders. These disorders are frequent in Martinique.
      Physiotherapeutic rehabilitation is essential because these disorders are generally non
      dopa-sensitive.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient posture
time frame: After 8 weeks of reeducation
description: Measure in centimetres from the arrow to C7
measure: Spinal muscle strength
time frame: After 8 weeks of reeducation
description: Static contraction measured in holding time in seconds
measure: Spinal muscle strength
time frame: After 8 weeks of reeducation
description: Isokinetic contraction measured by a force in Newton/Kg and an abdominal spinal ratio of 66%.
measure: Improvement of balance
time frame: After 8 weeks of reeducation
description: Increasing the score on the BERG BALANCE SCALE BETWEEN 0 - 56.
measure: Walking speed
time frame: After 8 weeks of reeducation
description: Carry out a 10-metre Walk Test
arm group label: Experimental
arm group type: Experimental
description: Patient with conventional rehabilitation session and isokinetic reeducation during 7 weeks
arm group label: Control
arm group type: Other
description: Patient with conventional rehabilitation session during 7 weeks
intervention type: Other
intervention name: Isokinetic reeducation
description: Conventional rehabilitation session and isokinetic during 7 weeks
arm group label: Experimental
intervention type: Other
intervention name: Conventional reeducation
description: Conventional rehabilitation session during 7 weeks
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sabine SOPHIA
role: Principal Investigator
affiliation: CHU Martinique
last name: Sophia SABINE
phone: +596596488056
email: sophia.sabine@chu-martinique.fr
last name: Corine CARPIN
phone: +596596592696
phone ext: 3382
email: corine.carpin@chu-martinique.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: Martinique
url: https://www.elitemedicale.fr/media/documentations/Easytech/isocinetisme/Isocinetique_easytech_guide_clinique.pdf
description: Isocinetique_easytech_guide_clinique.pdf
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
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.
PMID: 25552609
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.
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.
PMID: 17016120
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.
PMID: 25806509
citation: Edouard P, Degache F. Guide d'isocinétisme, L'évaluation isocinétique des concepts aux conditions sportives et pathologiques. Elsevier Masson;09/2016.
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.
PMID: 29525296
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.
PMID: 25997862
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.
PMID: 27097000
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.
PMID: 20435478
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.
PMID: 25260231
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.
PMID: 20138321
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.
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No