- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745834
The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability
The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability - a Case-control Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shmuel Springer, PhD
- Phone Number: +972-584572869
- Email: shmuels@ariel.ac.il
Study Locations
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Zrifin, Israel
- Recruiting
- IDF Medical Corp
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Contact:
- Uri Gottlieb, BPT
- Phone Number: +972-54-2022767
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
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: Chronic Ankle Instability
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.
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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.
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Experimental: Healthy controls
Healthy soldiers who are not suffering from chronic ankle instability, will go through Gait analysis intervention.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stride time variability
Time Frame: Day 1
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Coefficient of variance of the stride time, measured in % by the OPTOGait system
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Day 1
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Stride length variability
Time Frame: Day 1
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Coefficient of variance of the stride length, measured in % by the OPTOGait system
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual task general score
Time Frame: Day 1
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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).
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Day 1
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shmuel Springer, PhD, Researcher
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDF-1482-2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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