Gait Retraining in Patients With Joint Hypermobility Synd... | NCT03575182

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

NCT03575182

Sponsor

University of South Florida

Status

Unknown status

Last Update Posted

Jul 2, 2018Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Joint Hypermobility
Ehlers-Danlos Syndrome
Hyperextension Knees

Interventions

Gait retraining program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Estimated

Primary Completion Date

Oct 31, 2019Estimated

Completion Date

Oct 31, 2020Estimated

First Submitted Date

Jun 21, 2018

First Submission Date that Met QC Criteria

Jun 21, 2018

First Posted Date

Jul 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2018

Last Update Posted Date

Jul 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gait retraining program	Experimental		Other: Gait retraining program
Physical therapy standard care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gait retraining program	Other	Supervised gait retraining with verbal and real-time visual feedback.	Gait retraining program

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Teran Wodzinski, PT, PhD	Contact	(813) 974-4677		pterany@health.usf.edu

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007593	Joint Instability
D004535	Ehlers-Danlos Syndrome

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D020141	Hemostatic Disorders
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided