- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04083391
Flexibility Deficit in Chronic Ankle Instability
September 5, 2019 updated by: Abd Elhady Samy Abu Mandour, Cairo University
Is Hamstring Flexibility Affected in Chronic Ankle Instability
chronic ankle instability could be associated with some proximal deficits as in hip and knee regions.
these deficits include alternations in motor neurons pools excitability, muscle strength, kinematics and kinetics.
this study add muscle inflexibility to the preciouse literature.
Study Overview
Status
Completed
Conditions
Detailed Description
Background: influence of a localized injury in a distal joint on the function of proximal muscles is an important consideration in assessment and treatment of musculoskeletal injuries.
Up to the investigator's knowledge, there is no study assess flexibility changes in CAI.
Objectives: The objective of this study is to investigate Hamstring flexibility in CAI.
Material and methods: The study conducted on 42 subjects with unilateral CAI and controls had measure of hamstring flexibility using digital inclinometer during passive knee extension test .Results: Revealed statistical and clinical significant difference between non-injured control group and CAI group with decreased hamstring flexibility in the later.
Conclusion: CAI subjects have proximal muscular affection include hamstring tightness which may alter sacroiliac joint stability and subsequently back pain.
Study Type
Observational
Enrollment (Actual)
42
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients clinic faculty of physical therapy Cairo university
Description
Inclusion Criteria:
- The control group was self-reported to be healthy
- Had no ankle injury history
- Matched with CAI patients in gender, dominance side and simulated injured side
- CAI group had a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset which required a period of protected weight bearing and/or immobilization at least one day
- Patient reported a tendency for the ankle to give way and/or recurrent ankle sprain
- Perceives that the ankle was chronically weaker, more painful and/or less functional than the other ankle or than before first
Exclusion Criteria:
- Had a history of lower extremity injury
- Surgery or fracture
- History of low back dysfunction that required medical or surgical intervention within the last year, Current participation in formal or informal rehabilitation
- History of hamstring strain
- Bilateral ankle sprain injury
- Ankle injury within 3 months of participation
- History of ankle fracture and any neuromuscluskeletal disease could affect the condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
CAI group
assessment had been done to this group that include patients with ankle sprain injury from more than one year and complain with repetitive injuries, giving way and instability feelings
|
non injured ankle group
assessment had been done to this group that include control participants had not injured their ankle before and matched with CAI in age, gender, dominant side
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamstring muscle flexibility
Time Frame: throughout the study average 1 year
|
angle between tibia and femur during passive knee extension test
|
throughout the study average 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Afaf Tahoon, Master, assistant lecturer faculty of physical therapy Cairo university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2016
Primary Completion (Actual)
December 30, 2016
Study Completion (Actual)
March 9, 2017
Study Registration Dates
First Submitted
August 23, 2019
First Submitted That Met QC Criteria
September 5, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 5, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
IPD had been planed to be shared with research team only through specific username and password
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Chronic Ankle Instability
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Gwendolyn VuurbergZimmer Biomet; Albert Schweitzer Hospital; Centro Hospitalar do Porto; Amphia Hospital and other collaboratorsRecruitingChronic Ankle InstabilityNetherlands, Portugal, Switzerland
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University of North Carolina, Chapel HillAcademy of Orthopaedic Physical TherapyCompletedChronic Ankle InstabilityUnited States
-
Linnaeus UniversityCompletedChronic Ankle InstabilitySweden
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Yeditepe UniversityCompleted
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Istanbul Gelisim UniversityCompleted
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National Yang Ming UniversityCompletedChronic Ankle InstabilityTaiwan
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University of VirginiaCompleted
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Chonbuk National University HospitalCompletedChronic Ankle InstabilityKorea, Republic of
-
University GhentCompletedChronic Ankle InstabilityBelgium
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Academisch Medisch Centrum - Universiteit van Amsterdam...Amsterdam UMC, location VUmc; Flevoziekenhuis; Slotervaart HospitalRecruiting