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

Primary Purpose

Ehlers-Danlos Syndrome Hypermobility Type (hEDS)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Compressive garment and Somatosensori Remediation
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ehlers-Danlos Syndrome Hypermobility Type (hEDS)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Caen Univerity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Compressive garment associated with physical therapy

Low compressive garment associated with physical therapy

Arm Description

Outcomes

Primary Outcome Measures

analysis of center of pressure displacements on force platform
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).

Secondary Outcome Measures

Full Information

First Posted
July 10, 2019
Last Updated
February 10, 2023
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04020107
Brief Title
Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
Acronym
VITALISED
Official Title
Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
November 25, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ehlers-Danlos Syndrome Hypermobility Type (hEDS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compressive garment associated with physical therapy
Arm Type
Active Comparator
Arm Title
Low compressive garment associated with physical therapy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Compressive garment and Somatosensori Remediation
Intervention Description
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
Primary Outcome Measure Information:
Title
analysis of center of pressure displacements on force platform
Description
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).
Time Frame
at month 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Caen Univerity Hospital
City
Caen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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