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Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome

Primary Purpose

Joint Hypermobility, Ehlers-Danlos Syndrome, Hyperextension Knees

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gait retraining program
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Hypermobility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ehlers-Danlos Syndrome Hypermobile type as defined in the 2017 international Ehlers-Danlos Syndrome classification

Exclusion Criteria:

  • Other heritable and acquired connective tissue disorders, autoimmune rheumatologic conditions, pregnancy, history of lower limb surgery, cardiovascular limitations, visual limitations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Gait retraining program

    Physical therapy standard care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Knee Joint Range of Motion

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2018
    Last Updated
    June 21, 2018
    Sponsor
    University of South Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03575182
    Brief Title
    Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome
    Official Title
    Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    October 31, 2019 (Anticipated)
    Study Completion Date
    October 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of South Florida

    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
    This study evaluates the efficacy of gait retraining with biofeedback in the treatment of neuromusculoskeletal symptoms in patients with Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome. Half of participants will participate in a gait retraining program, while the other half will continue standard care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Joint Hypermobility, Ehlers-Danlos Syndrome, Hyperextension Knees

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gait retraining program
    Arm Type
    Experimental
    Arm Title
    Physical therapy standard care
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Gait retraining program
    Intervention Description
    Supervised gait retraining with verbal and real-time visual feedback.
    Primary Outcome Measure Information:
    Title
    Knee Joint Range of Motion
    Time Frame
    4-5 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ehlers-Danlos Syndrome Hypermobile type as defined in the 2017 international Ehlers-Danlos Syndrome classification Exclusion Criteria: Other heritable and acquired connective tissue disorders, autoimmune rheumatologic conditions, pregnancy, history of lower limb surgery, cardiovascular limitations, visual limitations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patricia Teran Wodzinski, PT, PhD
    Phone
    (813) 974-4677
    Email
    pterany@health.usf.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome

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