Joint HypermobilityNCT03575182
Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome
A study testing Gait retraining program in people with Joint Hypermobility and Ehlers-Danlos Syndrome, run by University of South Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Joint Hypermobility, Ehlers-Danlos Syndrome, Hyperextension Knees
- What is being tested?
- Gait retraining program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ehlers-Danlos Syndrome Hypermobile type as defined in the 2017 international Ehlers-Danlos Syndrome classification
Who cannot join
- Other heritable and acquired connective tissue disorders, autoimmune rheumatologic conditions, pregnancy, history of lower limb surgery, cardiovascular limitations, visual limitations.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Gait retraining program
- Medical subject headings
- Joint Instability, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait retraining programOther
Supervised gait retraining with verbal and real-time visual feedback.
| Study group | Role | What they receive |
|---|---|---|
| Gait retraining program | Experimental | Not described Receives: Other: Gait retraining program |
| Physical therapy standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Joint Range of Motion
Measured: 4-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint HypermobilityStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575182
- Sponsor's protocol ID
- USF-JHS/hEDS-062118
- Status last verified
- Jun 2018
- First submitted
- 21 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome
- ClinicalTrials.gov ID
- NCT03575182
- Acronym / sponsor ID
- USF-JHS/hEDS-062118
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait retraining program | Experimental | Other: Gait retraining program |
| Physical therapy standard care | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ehlers-Danlos Syndrome Hypermobile type as defined in the 2017 international Ehlers-Danlos Syndrome classification
Key exclusion criteria (1 listed)
- Other heritable and acquired connective tissue disorders, autoimmune rheumatologic conditions, pregnancy, history of lower limb surgery, cardiovascular limitations, visual limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait retraining programSupervised gait retraining with verbal and real-time visual feedback. | Other | Gait retraining program |
Primary outcome
Knee Joint Range of Motion
Time frame: 4-5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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A Study on Associations Between Multidimensional Human Phenotypic Traits and Human Growth and Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Gait retraining program in people with Joint Hypermobility and Ehlers-Danlos Syndrome, run by University of South Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Teran Wodzinski, PT, PhD ((813) 974-4677, pterany@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Joint Range of Motion (time frame: 4-5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.