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

Chronic Instability of Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745834
• Other study ID #: IDF-1482-2014
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2016
• Last updated: April 19, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Medical Corps, Israel Defense Force
• Contact: Shmuel Springer, PhD
• Phone: +972-584572869
• Email: shmuels[@]ariel.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Instability of Joint
• Joint Instability

Intervention

Other:
• Gait analysis
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.

Locations

Country	Name	City	State
Israel	IDF Medical Corp	Zrifin

Sponsors (2)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force	Ariel University Center of Samaria

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stride time variability	Coefficient of variance of the stride time, measured in % by the OPTOGait system	Day 1	No
Primary	Stride length variability	Coefficient of variance of the stride length, measured in % by the OPTOGait system	Day 1	No
Secondary	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).	Day 1	No