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

Intervention / Treatment

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

  • Poland
    • 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
Other: ankle joint brace 1
The influence of ankle joint brace 1 on gait biomechanics
Other: ankle joint brace 2
The influence of ankle joint brace 2 on gait biomechanics
Other: ankle joint brace 3
The influence of ankle joint brace 3 on gait biomechanics
Other: ankle joint brace 4
The influence of ankle joint brace 4 on gait biomechanics
Other: ankle joint brace 5
The influence of ankle joint brace 5 on gait biomechanics
Experimental: young adults with chronic ankle joint instability
Gait measured by Vicon Nexus System
Other: ankle joint brace 1
The influence of ankle joint brace 1 on gait biomechanics
Other: ankle joint brace 2
The influence of ankle joint brace 2 on gait biomechanics
Other: ankle joint brace 3
The influence of ankle joint brace 3 on gait biomechanics
Other: ankle joint brace 4
The influence of ankle joint brace 4 on gait biomechanics
Other: ankle joint brace 5
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

Barbara Łysoń

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.

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