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The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability

Primary Purpose

Chronic Instability of Joint

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Gait analysis

About this trial

This is an interventional basic science trial for Chronic Instability of Joint

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

IDF Medical CorpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chronic Ankle Instability

Healthy controls

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Stride time variability

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

Stride length variability

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

Secondary Outcome Measures

Dual task general score

Participants will be asked to count backward, reducing 7 at a time, starting at different 3 digits number. The outcome measure is a calculation of the number of total answers multiple by (number of correct answers - number of wrong answers).

Full Information

NCT ID

NCT02745834

First Posted

March 15, 2016

Last Updated

April 19, 2016

Sponsor

Medical Corps, Israel Defense Force

Collaborators

Ariel University

1. Study Identification

Unique Protocol Identification Number

NCT02745834

Brief Title

The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability

Official Title

The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability - a Case-control Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical Corps, Israel Defense Force

Collaborators

Ariel University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This case-control study will compare the different gait parameters such as stride time and stride length variability in different gait conditions (e.g., normal speed, normal speed with dual task, fast speed and fast speed with dual task) between healthy individuals and patients who suffer from chronic ankle instability. the measurements will be collected using the OPTOGait system installed on a treadmill.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Instability of Joint

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chronic Ankle Instability

Arm Type

Experimental

Arm Description

Arm Title

Healthy controls

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Gait analysis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Stride time variability

Description

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

Time Frame

Day 1

Title

Stride length variability

Description

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

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Dual task general score

Description

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shmuel Springer, PhD

Phone

+972-584572869

shmuels@ariel.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shmuel Springer, PhD

Organizational Affiliation

Researcher

Official's Role

Principal Investigator

Facility Information:

Facility Name

IDF Medical Corp

City

Zrifin

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uri Gottlieb, BPT

Phone

+972-54-2022767

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be published after statistical analysis only.

Citations:

PubMed Identifier

28732483

Citation

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.

Results Reference

derived

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The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability

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