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Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children (PROPENSIX)

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ClinicalTrials.gov Identifier: NCT02086214
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
Marc Sautelet Centre (Villeneuve d'Ascq, France)
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP).

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Proprioceptive pressure therapy Device: Control Not Applicable

Detailed Description:
The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
Actual Study Start Date : December 21, 2012
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Proprioceptive pressure therapy
Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
Device: Proprioceptive pressure therapy
Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
Other Name: Proprioceptive pressure therapy by Medical Z

Placebo Comparator: Control
LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.
Device: Control
LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.




Primary Outcome Measures :
  1. Assisting Hand Assessment performance [ Time Frame: 6 months ]
    Assisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities.


Secondary Outcome Measures :
  1. Upper Extremity skill Test (QUEST) [ Time Frame: 6 months ]
    Upper Extremity skill Test is a functional test to assess upper limb mobility for children with unilateral upper limb disabilities.

  2. Somatosensory Evoked Potentials (SEP) [ Time Frame: 6 months ]
    Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction



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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with upper limb with pre/peri birth etiologic CP.
  • Children aged 5 to 10 years

Exclusion Criteria:

  • Children with language dysfunction
  • LYCRA® allergia
  • Botulic Toxin injection on upper limb 4 month before inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086214


Contacts
Contact: Laurent R BEGHIN, PhD +33 3 20 44 68 91 laurent.beghin@chru-lille.fr
Contact: Laurence GOTTRAND, MD + 33 3 28 80 07 70

Locations
France
CHU Recruiting
Amiens, France
Principal Investigator: Séverine FRITOT, MD         
Service d'Education et de Soins Spécialisés à domicile_APF de Creil Recruiting
Creil, France
Principal Investigator: Yasser MOHAMMAD, MD         
CHU Recruiting
Reims, France
Principal Investigator: Mathilde TOUSSAINT, MD         
Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin Recruiting
Toulouse, France
Principal Investigator: Catherine DONSKOFF, MD         
Centre Marc Sautelet Recruiting
Villeneuve d'Ascq, France, 59653
Contact: Laurence GOTTRAND, MD    +33 3 28 80 07 70      
Principal Investigator: Laurent GOTTRAND, MD         
Sponsors and Collaborators
University Hospital, Lille
Marc Sautelet Centre (Villeneuve d'Ascq, France)
Investigators
Principal Investigator: Laurent GOTTRAND, MD Centre Marc Sautelet, Villeneuve d'Ascq, France

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02086214     History of Changes
Other Study ID Numbers: 2011_01
N°19/16, Axe 1.11, ( Other Grant/Funding Number: PHRC-2011 )
2011-A01129-32 ( Other Identifier: ID-RCB number, AFSSAPS )
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
Upper limb
Proprioceptive pressure therapy
Children
Assisting Hand Assessment performance

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases