NCT04586036

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

October 8, 2020

Last Update Submit

February 28, 2021

Conditions

Keywords

ankle joint braceatfloxford foot model

Outcome Measures

Primary Outcomes (1)

  • Oxford Foot Model Angles

    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

Study Arms (2)

young healthy adults

EXPERIMENTAL

Gait measured by Vicon Nexus System

Other: ankle joint brace 1Other: ankle joint brace 2Other: ankle joint brace 3Other: ankle joint brace 4Other: ankle joint brace 5

young adults with chronic ankle joint instability

EXPERIMENTAL

Gait measured by Vicon Nexus System

Other: ankle joint brace 1Other: ankle joint brace 2Other: ankle joint brace 3Other: ankle joint brace 4Other: ankle joint brace 5

Interventions

The influence of ankle joint brace 1 on gait biomechanics

young adults with chronic ankle joint instabilityyoung healthy adults

The influence of ankle joint brace 2 on gait biomechanics

young adults with chronic ankle joint instabilityyoung healthy adults

The influence of ankle joint brace 3 on gait biomechanics

young adults with chronic ankle joint instabilityyoung healthy adults

The influence of ankle joint brace 4 on gait biomechanics

young adults with chronic ankle joint instabilityyoung healthy adults

The influence of ankle joint brace 5 on gait biomechanics

young adults with chronic ankle joint instabilityyoung healthy adults

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-35
  • female or male
  • good health condition
  • chronic ankle joint instability (for chronic ankle instability group)

You may not qualify if:

  • lower limb injuries (last 6 months)
  • extreme sports athletes
  • no chronic ankle joint instability (for chronic ankle instability group)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Józef Piłsudski University of Physical Education in Warsaw

Warsaw, Mazowsze, 00-968, Poland

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
master of science

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 14, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

January 20, 2020

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations