Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS) (VITALISED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020107
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
analysis of center of pressure displacements on force platform [ Time Frame: at month 8 ]
The main evaluation criterion is the complexity of postural control after 8 months of treatment (M8) through an analysis of the organization postural fluctuations (i.e. analysis of center of pressure displacements on force platforms6).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
Official Title  ICMJE Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
Brief Summary

In the absence of a medical consensus, the current management of Ehlers-Danlos Syndrome hypermobility type (hEDS) remains very speculative That's why investigators want in this study to demonstrate the beneficial contribution of an innovative therapeutic strategy combining reprogramming and substitution somatosensory. This therapy is based primarily on the somesthetic substitution provided by compression garments(VC). Indeed, the VC port associated with stimulation of the somesthetic system via a specific program of physiotherapy (e.e. centered on body awareness through movement) could potentiate the effectiveness of care, and therefore enhance its long-term beneficial effect. The patient could thus regain his mobility, his functional independence, and thus considerably increase its quality of life. Thereafter, the practice of an adapted physical activity (APA), by the sensory stimulation induced and its playful nature, will allow patients to preserve and sustain the benefits of taking load previously carried out. Validation of this therapeutic approach would offer an effective solution may subsequently be proposed to the entire medical profession as reference support in the treatment of the hEDS.

This study plans to include, over a period of two years, 40 patients with hypermobile Ehlers-Danlos syndrome and 40 healthy volunteers controls. Patients will be followed for a period of one year divided into 3 periods of 4 months, between which they will be evaluated in order to quantify the impact of the intervention performed at each stage of the protocol.

Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive garments or with low compressive garment during the next 4 months in association with proprioceptive physical therapy. Finally, the 4 last months, patient will participate in an APA with both dance sessions strengthening the body diagram and stretching sessions.

The aim of this work is therefore to evaluate the effect of a treatment specifically oriented towards somatosensory remediation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
Intervention  ICMJE Other: Compressive garment and Somatosensori Remediation
Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive or low compressive garments associated with specific proprioceptive physiotherapy program during the next 4 months. Finally, the 4 last months, patient will made adapted physical activity with both dance sessions strengthening the body diagram and stretching sessions
Study Arms  ICMJE
  • Active Comparator: Compressive garment associated with physical therapy
    Intervention: Other: Compressive garment and Somatosensori Remediation
  • Placebo Comparator: Low compressive garment associated with physical therapy
    Intervention: Other: Compressive garment and Somatosensori Remediation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For EDS patients :

  • Subjects aged 18 to 40,
  • SEDh patients newly diagnosed for less than 2 years according to international criteria of 2017,
  • Having a Body Mass Index (BMI) of less than 30,
  • Affiliated to a social security scheme,
  • Having read the information document and given in writing their free and informed consent to participate in the study.

For healthy volunteers :

  • Subjects aged 18 to 40,
  • Having a Body Mass Index (BMI) of less than 30,
  • Having a Beigthon score <5 (no joint hypermobility),
  • Having normal muscle strength,
  • Affiliated to a social security scheme,
  • Having read the information document and given in writing their free and informed consent to participate in the study.

Exclusion Criteria:

For EDS patients :

  • Subjects under 18,
  • Proprioceptive physiotherapy (Huber 360 platform type, LPG) in progress or already performed,
  • previous treatment of hEDS capable of limiting the effects of rehabilitation (e.g. orthodontics, orthoptics),
  • Diagnosis of other connective tissue abnormalities,
  • Earlier prescription of compression garments,
  • Pregnant or lactating women,
  • Lack of effective contraception during the study period for women
  • Person under tutorship or curatorship, or deprived of liberty by judicial or administrative decision,
  • Mental or physical impossibility to agree to participate in the study,
  • Known allergy to one of the components of compression garments,
  • Disabling motor impairment, or limiting the performance of motor and psychomotor tests.
  • Simultaneous participation in another clinical study.

For healthy volunteers :

  • Subjects under 18,
  • History of vascular, neurological, musculoskeletal or vestibular disorders,
  • Having orthoptic, orthopedic or orthodontic disorders,
  • Previous history or progressive disease of vascular, ophthalmological, neurological, musculoskeletal condition, or vestibular condition
  • Pregnant or lactating women,
  • Person under tutorship or curatorship, or deprived of liberty by judicial or administrative decision,
  • Mental or physical impossibility to agree to participate in the study,
  • Simultaneous participation in another clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020107
Other Study ID Numbers  ICMJE 17-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Caen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP