- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586036
The Evaluation of Ankle Joint Braces Efficiency
February 28, 2021 updated by: Barbara Łysoń
The project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury.
Authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
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.
Study Locations
-
-
Mazowsze
-
Warsaw, Mazowsze, Poland, 00-968
- Józef Piłsudski University of Physical Education in Warsaw
-
-
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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-35
- female or male
- good health condition
- chronic ankle joint instability (for chronic ankle instability group)
Exclusion Criteria:
- lower limb injuries (last 6 months)
- extreme sports athletes
- no chronic ankle joint instability (for chronic ankle instability group)
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: young healthy adults
Gait measured by Vicon Nexus System
|
The influence of ankle joint brace 1 on gait biomechanics
The influence of ankle joint brace 2 on gait biomechanics
The influence of ankle joint brace 3 on gait biomechanics
The influence of ankle joint brace 4 on gait biomechanics
The influence of ankle joint brace 5 on gait biomechanics
|
Experimental: young adults with chronic ankle joint instability
Gait measured by Vicon Nexus System
|
The influence of ankle joint brace 1 on gait biomechanics
The influence of ankle joint brace 2 on gait biomechanics
The influence of ankle joint brace 3 on gait biomechanics
The influence of ankle joint brace 4 on gait biomechanics
The influence of ankle joint brace 5 on gait biomechanics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxford Foot Model Angles
Time Frame: 2 hours
|
Ankle angles, Hindfoot Tibia angles and Forefoot Hindfoot angles caculated by Oxford Foot Model, colected with the use of Vicon Motion Capture system
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
October 8, 2020
First Submitted That Met QC Criteria
October 8, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
February 28, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DS-295
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.
Clinical Trials on Ankle Injuries
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Hadassah Medical OrganizationCompleted
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Oregon State UniversityTerminatedNeural Inhibition | Injuries, AnkleUnited States
-
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MTI UniversityCairo UniversityCompleted
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Clinical Trials on ankle joint brace 1
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Sport and Spine Rehab Clinical Research FoundationCompletedAnkle SprainsUnited States
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Vrije Universiteit BrusselUniversitair Ziekenhuis BrusselNot yet recruiting
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BayerCompleted
-
University of North Carolina, Chapel HillNational Center for Complementary and Integrative Health (NCCIH)CompletedChronic Instability of Joint | Ankle Inversion SprainUnited States
-
Walter van der WeegenGelre Hospitals; Medinova ClinicsRecruitingAnkle Sprains | Talofibular; Sprain (Strain)Netherlands
-
Vanderbilt UniversityTerminatedElbow Fracture | Upper Extremity Fracture | Fractures, Comminuted | Elbow Dislocation | Upper Extremity DislocationUnited States
-
The Hospital for Sick ChildrenThe Physicians' Services Incorporated FoundationCompleted
-
Canadian Memorial Chiropractic CollegeMcMaster UniversityTerminatedAnkle Inversion SprainCanada
-
North Carolina State UniversityUniversity of North Carolina, Chapel Hill; U.S. National Science FoundationRecruitingIncomplete Spinal Cord Injury | Transverse MyelitisUnited States
-
University of MiamiShireTerminated