NCT03575182

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

June 21, 2018

Last Update Submit

June 21, 2018

Conditions

Joint HypermobilityEhlers-Danlos SyndromeHyperextension Knees

Outcome Measures

Primary Outcomes (1)

  • Knee Joint Range of Motion

    4-5 weeks

Study Arms (2)

Gait retraining program

EXPERIMENTAL
Other: Gait retraining program

Physical therapy standard care

NO INTERVENTION

Interventions

Gait retraining programOTHER

Supervised gait retraining with verbal and real-time visual feedback.

Gait retraining program

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Joint InstabilityEhlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Central Study Contacts

Patricia Teran Wodzinski, PT, PhD

CONTACT

(813) 974-4677pterany@health.usf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 2, 2018

Study Start

October 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2020

Last Updated

July 2, 2018

Record last verified: 2018-06