NCT02745834

Brief Summary

Case-control study to evaluate gait parameters during different conditions between patients who suffer from chronic ankle instability and healthy individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

March 15, 2016

Last Update Submit

April 19, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stride time variability

    Coefficient of variance of the stride time, measured in % by the OPTOGait system

    Day 1

  • Stride length variability

    Coefficient of variance of the stride length, measured in % by the OPTOGait system

    Day 1

Secondary Outcomes (1)

  • Dual task general score

    Day 1

Study Arms (2)

Chronic Ankle Instability

EXPERIMENTAL

Soldiers who suffer from chronic ankle instability who had a first major ankle sprain one year or more ago, and did not sustained any major ankle sprain in the last two months, will go through Gait analysis intervention.

Other: Gait analysis

Healthy controls

EXPERIMENTAL

Healthy soldiers who are not suffering from chronic ankle instability, will go through Gait analysis intervention.

Other: Gait analysis

Interventions

Gait will be analysed while participants will walk on a treadmill at different self selected speeds, using the OPTOGait system. Spatiotemporal measures are collected without the use of any markers.

Chronic Ankle InstabilityHealthy controls

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • history of at least one significant ankle sprain which occurred at least 12 months prior to enrolment in the study and was diagnosed by a physician or a physical therapist using clinical examination classifications described by Malliaropoulos et al
  • history of at least two episodes of 'giving way', and feelings of ankle joint instability in the previously injured ankle joint of 1 year post-initial sprain
  • the most recent injury occurred more than 6 weeks prior to the study enrolment
  • the ability to apply full weight bearing on the injured lower extremity with no more than mild discomfort

You may not qualify if:

  • evidence of a concomitant injury (such as a bony injury or significant muscular/tendon injury)
  • previous ankle surgery
  • other pathological conditions or surgical procedures in lower extremity
  • neurological/vestibular or any other balance disorder.
  • The control group included healthy participants with no current or previous conditions that could affect proprioception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDF Medical Corp

Zrifin, Israel

RECRUITING

Related Publications (1)

  • Springer S, Gottlieb U. Effects of dual-task and walking speed on gait variability in people with chronic ankle instability: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jul 21;18(1):316. doi: 10.1186/s12891-017-1675-1.

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Shmuel Springer, PhD

    Researcher

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shmuel Springer, PhD

CONTACT

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

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 20, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Data will be published after statistical analysis only.

Locations