- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228848
New Triple Hop Test Quality Assessment Tool
Examination of New Triple Hop Test Assessment Tool for Adults and Adolescents, Healthy and After Anterior Cruciate Ligament Injury
This study will develop a new jump assessment tool for the Triple Hop Test, and will test its reliability on adolescent and adult, healthy and post- anterior cruciate ligament (ACL) population.
Creating a new assessment test for a jump test that incorporates the known movement components that are important after an ACL injury can improve patient evaluation, decision for return to sport activity and injury prevention.
Study Overview
Detailed Description
Study population- Adults, women and men aged 20-45, boys and girls aged 12-15. uninjured population: non symptomatic subjects, without major injury in their history. Injured population: ACL injured subjects, 9-12 month after beginning of treatment/surgery.
Stages of study:
stage 1- The investigators will create a new high-quality literature-based assessment test for the triple hop test (NTHT). The test will have 10 sections, its score ranges from 0 to 14 points and a high score means poor performance.
Stage 2- Performing reliability tests between and within the testers for NTHT. The tests will be done with the help of video photography of NTHT.
Stage 3- Performing NTHT and THT tests on healthy adult and adolescent subjects and on ACL adult and adolescent subjects, assessing the NTHT by watching video performance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Haifa, Israel
- Haifa University, Department of PHysical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria uninjured population:
- non symptomatic subjects
- without major injury in their history.
Inclusion Criteria injured population:
- ACL injured subjects
- 9-12 month after beginning of treatment/surgery.
Exclusion Criteria uninjured population:
- acute pain
- knee instability symptoms
- history of lower leg injury
- unable to jump on one leg
- knee ligament injury.
Exclusion Criteria Injured population:
- late in rehabilitation program
- unable to jump or run
- instability symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy adult
Each participants will be asked to perform triple hop test on a straight line and to stand stable at the end of the jump.
Two jumps will be performed on each leg, with 1 minute rest between them.
The jumps will be recorded via video.
Legs muscle strength will be assessed using hand held dynamometer
|
New jumping assessment will be performed in all included study groups.
This new assessment includes quality evaluation.
|
Experimental: ACL adult
Each participants will be asked to perform triple hop test on a straight line and to stand stable at the end of the jump.
Two jumps will be performed on each leg, with 1 minute rest between them.
The jumps will be recorded via video.
Legs muscle strength will be assessed using hand held dynamometer
|
New jumping assessment will be performed in all included study groups.
This new assessment includes quality evaluation.
|
Active Comparator: Healthy adolescent
Each participants will be asked to perform triple hop test on a straight line and to stand stable at the end of the jump.
Two jumps will be performed on each leg, with 1 minute rest between them.
The jumps will be recorded via video.
Legs muscle strength will be assessed using hand held dynamometer
|
New jumping assessment will be performed in all included study groups.
This new assessment includes quality evaluation.
|
Experimental: ACL adolescent
Each participants will be asked to perform triple hop test on a straight line and to stand stable at the end of the jump.
Two jumps will be performed on each leg, with 1 minute rest between them.
The jumps will be recorded via video.Legs muscle strength will be assessed using hand held dynamometer
|
New jumping assessment will be performed in all included study groups.
This new assessment includes quality evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New triple hop test score
Time Frame: baseline
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the score ranges between 0-14.
lower score represent better jumping quality.
|
baseline
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triple hop test
Time Frame: baseline
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measurement of jumping distance(in cm) and symmetry between legs
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baseline
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muscle strength
Time Frame: baseline
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muscle strength in Newton, assessed by an hand held dynamometer.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gali Dar, PHd, University of Haifa
Publications and helpful links
General Publications
- Graziano J, Chiaia T, de Mille P, Nawabi DH, Green DW, Cordasco FA. Return to Sport for Skeletally Immature Athletes After ACL Reconstruction: Preventing a Second Injury Using a Quality of Movement Assessment and Quantitative Measures to Address Modifiable Risk Factors. Orthop J Sports Med. 2017 Apr 20;5(4):2325967117700599. doi: 10.1177/2325967117700599. eCollection 2017 Apr.
- Dekker TJ, Godin JA, Dale KM, Garrett WE, Taylor DC, Riboh JC. Return to Sport After Pediatric Anterior Cruciate Ligament Reconstruction and Its Effect on Subsequent Anterior Cruciate Ligament Injury. J Bone Joint Surg Am. 2017 Jun 7;99(11):897-904. doi: 10.2106/JBJS.16.00758.
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
- HU 1122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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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