NCT04228848

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 26, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

January 12, 2020

Last Update Submit

November 12, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • New triple hop test score

    the score ranges between 0-14. lower score represent better jumping quality.

    baseline

  • triple hop test

    measurement of jumping distance(in cm) and symmetry between legs

    baseline

  • muscle strength

    muscle strength in Newton, assessed by an hand held dynamometer.

    baseline

Study Arms (4)

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

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

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

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

Other: new triple hop test

Interventions

New jumping assessment will be performed in all included study groups. This new assessment includes quality evaluation.

ACL adolescentACL adultHealthy adolescentHealthy adult

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • non symptomatic subjects
  • without major injury in their history.
  • ACL injured subjects
  • month after beginning of treatment/surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifa University, Department of PHysical Therapy

Haifa, Israel

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Gali Dar, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 4 subgroups performing jump test
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of Physical therapy

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 14, 2020

Study Start

July 26, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

following study completion, a paper will be submitted to international professional journal

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months following end of study

Locations