- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05294783
The Single Leg Squat Test to Evaluate Dynamic Knee Stability After ACLR
The Single Leg Squat and Hold Test With Kinematic Analysis to Evaluate Dynamic Knee Stability in Patients With ACL Injury
Study Overview
Detailed Description
Injuries to the anterior cruciate ligament (ACL) are common in pivoting sports such as soccer, handball, basketball and rugby. The ultimate goal of ACL reconstruction for most athletes is return-to-play. Despite successful surgery and a demanding rehabilitation process, some athletes still failed to return to play, and for those who returned to play, some would suffer a second ACL injury. With surgical reconstruction of the ACL, static knee stability can be restored, but dynamic knee stability may not . Patients with ACL injury often experience symptoms such as knee instability, feelings of "giving way" during activities. Biomechanically, dynamic knee stability is considered as the ability to control the relative tibiofemoral displacements during loading.
Regular monitoring of the knee stability before and after ACL reconstruction is necessary for medical personnel to design the most suitable rehabilitation program. In contrast to jumping and hopping tasks, squatting tasks present a similar weight bearing profile during knee flexion, but without the potentially risky landing phase. As poor knee dynamic knee stability can be visualized as a wobbling knee (frequent knee movements). In order to quantitatively and objectively evaluate dynamic knee stability from observing the knee wobbling motion, we propose a single leg squat and hold task(SLSH) with kinematic analysis. Kinematic curve derived from the SLSH involves both the magnitudes and the frequency of the motion fluctuation. This study aims (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL-deficient patients who are scheduled for ACLR and healthy controls; and(2)to detect the changes in knee kinematic variations during SLSH following ACLR. We hypothesize that the ACL-deficient patients demonstrate greater knee kinematic variation than the healthy subjects and the knee kinematic variation will reduce after ACLR.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18-35;
- Participate in level I or level II sports with a Tegner score of more than 6 before injury(level I: sports involving jumping, cutting and pivoting, e.g.football, basketball etc; Level II: sports involving lateral movements, less pivoting than Level I eg. racket sports)
- Scheduled for ACLR because of unilateral ACL injury;
- Failure to meet any single criteria for a potential coper;
- Contralateral knee without history of injury.
Exclusion Criteria:
- Concomitant fracture, meniscus injury or full-thickness chondral injuries;
- preoperative radiographic signs of arthritis;
- Revision ACL surgery;
- With ankle pain, hip pain, low back pain or spine pathology;
- Woman with pregnancy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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ACL injured patients
All the ACL injured patients recruited underwent ACL reconstruction with the same group of surgeons lead by the same chief surgeon.
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ACL reconstruction is a standard surgery for ACL injured patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes from baseline knee range of flexion-extension at 3 months after ACLR
Time Frame: three months post-operatively
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knee range of flexion-extension will be measured during 10s holding phase of the single leg squat and hold test
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three months post-operatively
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Changes from baseline knee range of varus-valgus at 3 months after ACLR
Time Frame: three months post-operatively
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knee range of virus-valgus will be measured during 10s holding phase of the single leg squat and hold test
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three months post-operatively
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Changes from baseline knee range of internal-external rotation at 3 months after ACLR
Time Frame: one month pre-operatively and three months post-operatively
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knee range of internal-external rotation will be measured during 10s holding phase of the single leg squat and hold test
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one month pre-operatively and three months post-operatively
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Changes from baseline frequency of knee flexion-extension at 3 months after ACLR
Time Frame: three months post-operatively
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the frequency of the relative flexion-extension movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
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three months post-operatively
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Changes from baseline frequency of knee varus-valgus at 3 months after ACLR
Time Frame: three months post-operatively
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the frequency of the relative varus-valgus movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
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three months post-operatively
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Changes from baseline frequency of knee internal-external rotation
Time Frame: three months post-operatively
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he frequency of the relative internal-external movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
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three months post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes from baseline International Knee Documentation Committee(IKDC) score at 3 months after ACLR
Time Frame: three months post-operatively
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The IKDC is consisted of 10 questions about symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function
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three months post-operatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xin He, PhD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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