ACL InjuryNCT04228848
New Triple Hop Test Quality Assessment Tool
A study testing new triple hop test in people with ACL Injury, run by University of Haifa at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- new triple hop test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Jul 2020to 1 Oct 2021
- 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- non symptomatic subjects
- without major injury in their history.
- ACL injured subjects
- 9-12 month after beginning of treatment/surgery.
Who cannot join
- acute pain
- knee instability symptoms
- history of lower leg injury
- unable to jump on one leg
- knee ligament injury.
- late in rehabilitation program
- unable to jump or run
- instability symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ACL Injury
- Being tested
- new triple hop test
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new triple hop testOther
New jumping assessment will be performed in all included study groups. This new assessment includes quality evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult | Active comparator | 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 Receives: Other: new triple hop test |
| ACL adult | Experimental | 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 Receives: Other: new triple hop test |
| Healthy adolescent | Active comparator | 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 Receives: Other: new triple hop test |
| ACL adolescent | Experimental | 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 Receives: Other: new triple hop test |
What is being measured
The primary outcome is the main question the study is designed to answer.
New triple hop test score
the score ranges between 0-14. lower score represent better jumping quality.
Measured: baseline
triple hop test
measurement of jumping distance(in cm) and symmetry between legs
Measured: baseline
muscle strength
muscle strength in Newton, assessed by an hand held dynamometer.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start26 Jul 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 4 subgroups performing jump test
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gali Dar, University of Haifa
- Investigators
- Gali Dar, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228848
- Sponsor's protocol ID
- HU 1122
- Status last verified
- Nov 2021
- First submitted
- 12 Jan 2020
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: following study completion, a paper will be submitted to international professional journal
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.
PubMed 28451617Dekker 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.
PubMed 28590374
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of New Triple Hop Test Assessment Tool for Adults and Adolescents, Healthy and After Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT04228848
- Acronym / sponsor ID
- HU 1122
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 14 Jan 2020 (actual)
- 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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4 subgroups performing jump test
| Arm | Type | Receives |
|---|---|---|
| Healthy adult | Active comparator | Other: new triple hop testEach 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 |
| ACL adult | Experimental | Other: new triple hop testEach 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 |
| Healthy adolescent | Active comparator | Other: new triple hop testEach 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 |
| ACL adolescent | Experimental | Other: new triple hop testEach 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 |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- non symptomatic subjects
- without major injury in their history.
- ACL injured subjects
- 9-12 month after beginning of treatment/surgery.
Key exclusion criteria (8 listed)
- acute pain
- knee instability symptoms
- history of lower leg injury
- unable to jump on one leg
- knee ligament injury.
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 |
|---|---|---|
| new triple hop testNew jumping assessment will be performed in all included study groups. This new assessment includes quality evaluation. | Other | ACL adolescent, ACL adult, Healthy adolescent, Healthy adult |
Primary outcome
New triple hop test score
Time frame: baseline
the score ranges between 0-14. lower score represent better jumping quality.
triple hop test
Time frame: baseline
measurement of jumping distance(in cm) and symmetry between legs
muscle strength
Time frame: baseline
muscle strength in Newton, assessed by an hand held dynamometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Results publication: PubMed 28451617Graziano 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.
- Results publication: PubMed 28590374Dekker 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.
- Individual participant dataSharing planned: Yes. following study completion, a paper will be submitted to international professional journal
Related trials for ACL Injury
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
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Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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.
Gali Dar, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new triple hop test in people with ACL Injury, run by University of Haifa 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 8 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: finished, as of the sponsor's last update on 15 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New triple hop test score (time frame: baseline). The study lists 3 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 NCT04228848, which also lists 2 linked publications.
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 15 Nov 2021.