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

June 21, 2018 updated by: University of South Florida
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait retraining program
Other: Gait retraining program
Supervised gait retraining with verbal and real-time visual feedback.
No Intervention: Physical therapy standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Joint Range of Motion
Time Frame: 4-5 weeks
4-5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

October 31, 2019

Study Completion (Anticipated)

October 31, 2020

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USF-JHS/hEDS-062118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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