Chronic Instability of JointNCT02745834
The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability
A study testing Gait analysis in people with Chronic Instability of Joint, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
Case-control study to evaluate gait parameters during different conditions between patients who suffer from chronic ankle instability and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Instability of Joint
- What is being tested?
- Gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
IDF Medical Corp
Zrifin
Uri Gottlieb, BPT, +972-54-2022767
About this study
Official title: The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability - a Case-control Study
Case-control study to evaluate gait parameters during different conditions between patients who suffer from chronic ankle instability and healthy individuals.
Read the 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.
- Conditions
- Chronic Instability of Joint
- Being tested
- Gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gait analysis |
| Healthy controls | Experimental | Healthy soldiers who are not suffering from chronic ankle instability, will go through Gait analysis intervention. Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride time variability
Coefficient of variance of the stride time, measured in % by the OPTOGait system
Measured: Day 1
Stride length variability
Coefficient of variance of the stride length, measured in % by the OPTOGait system
Measured: Day 1
Secondary outcomes (1)
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Instability of JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Collaborators
- Ariel University
- Responsible party
- Sponsor
- Investigators
- Shmuel Springer, PhD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745834
- Sponsor's protocol ID
- IDF-1482-2014
- Status last verified
- Jan 2016
- First submitted
- 15 Mar 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published after statistical analysis only.
Publications
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.
PubMed 28732483
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability - a Case-control Study
- ClinicalTrials.gov ID
- NCT02745834
- Acronym / sponsor ID
- IDF-1482-2014
- Conditions
- Chronic Instability of Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Collaborators
- Ariel University
- Study start
- Oct 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Ankle Instability | Experimental | Other: Gait analysisSoldiers 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 controls | Experimental | Other: Gait analysisHealthy soldiers who are not suffering from chronic ankle instability, will go through Gait analysis intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysisGait 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. | Other | Chronic Ankle Instability, Healthy controls |
Primary outcome
Stride time variability
Time frame: Day 1
Coefficient of variance of the stride time, measured in % by the OPTOGait system
Stride length variability
Time frame: Day 1
Coefficient of variance of the stride length, measured in % by the OPTOGait system
1 secondary outcome
Dual task general score
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Derived from this study: PubMed 28732483Springer 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.
- Individual participant dataSharing planned: No. Data will be published after statistical analysis only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Springer, PhD principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis in people with Chronic Instability of Joint, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shmuel Springer, PhD (+972-584572869, shmuels@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride time variability (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.