Ankle Injuries, Imaging and Prevention Program Effectiven... | NCT06469099

Studies
Ankle Injuries, Imaging and Prevention Program Effectiveness in New Army Recruits

NCT06469099

Sponsor

University of Haifa

Status

Completed

Last Update Posted

Jan 26, 2026Actual

Enrollment

786Actual

Phase

Not Applicable

Conditions

Ankle Sprains

Interventions

excercises

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2024Actual

Primary Completion Date

Sep 15, 2025Actual

Completion Date

Sep 15, 2025Actual

First Submitted Date

Jun 16, 2024

First Submission Date that Met QC Criteria

Jun 16, 2024

First Posted Date

Jun 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2026

Last Update Posted Date

Jan 26, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gali Dar, Principal Investigator, University of HaifaPrincipal Investigator

Lead Sponsor

University of HaifaOTHER

Collaborators

Name	Class
Zinman College of Physical Education and Sports Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infantry recruits will undergo a musculoskeletal examination to assess tendon, muscle, proprioception, agility, and joint status. Afterward, an exercise intervention program will be implemented, followed by a concluding evaluation.

Detailed Description

Purpose: To evaluate ankle injuries in new infantry recruits, including their characteristics, association with imaging and functional measures, and the effectiveness of a preventive exercise program.

Methods: 650 new male infantry soldiers aged 18-23 will be recruited to participate in the study at the beginning of their military training. At the beginning and the end of the training (after approximately six months), the soldiers will be assessed for the following: 1. Demographics (height, weight, leg length, BMI calculation), 2. Proprioception ability (Active Movement Extent Discrimination Apparatus AMEDA), 3. Dynamic balance (Y-Balance Test YBT), 4. Leg muscle strength (bilateral heel rise test), 5. Hip strength (hand-held dynamometer), 6. Ankle agility (hexagon agility hop test), 7. Ankle stability (Anterior Drawer Test, musculoskeletal ultrasound for the Anterior Talofibular Ligament), 8. Achilles tendon structure (Ultrasound tissue Characterization UTC), 9. Aerobic ability (3000 meters run, will be recorded by the fitness instructors at the training base). In addition, the soldiers will fill out a previous ankle sprains questionnaire, pre-induction physical activity questionnaire, the Cumberland Ankle Instability Tool (CAIT) for ankle perceived instability, and the Ankle Fear Avoidance Beliefs Questionnaire (ankle-FABQ).

The soldiers will perform a constructed ankle sprain prevention program for five minutes every day during the six-month length of the study. Every 1-2 weeks, the researcher will arrive at the training base to monitor ankle injuries. Those who are diagnosed with a sprain will undergo ultrasound evaluations, which will be performed every few weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

786Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
research group	Experimental	active exercises for few weeks	Other: excercises
control	No Intervention	control group - no intervention, continue their routine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
excercises	Other	exercises for strength and balance	research group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proprioception ability	Active Movement Extent Discrimination Apparatus AMEDA	baseline, end of intervention
balance	Y balance test	baseline, end of intervention
Leg muscle strength	bilateral heel rise test	baseline, end of intervention
Hip muscle strength	hand held dynamometer	baseline, end of intervention
Ankle agility	hexagon agility hop test	baseline, end of intervention
Ankle stability	Anterior Drawer Test, musculoskeletal ultrasound for the Anterior Talofibular Ligament	baseline, end of intervention
Achilles tendon structure	Ultrasound tissue Characterization for the percentage of fibers types	baseline, end of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

soldiers ages 18-22

Exclusion Criteria:

knows disease of the bones
before orthopedic surgery

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

infantry soldiers

Minimum Age

18 Years

Maximum Age

22 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gali Dar, Prof.	University of Haifa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Academic college Levinsky-Wingate at the Wingate Institute		Netanya			Israel

Condition Browse Module

MeSH Terms

ID	Term
D016512	Ankle Injuries
D014947	Wounds and Injuries
D009043	Motor Activity

Ancestor Terms

ID	Term
D007869	Leg Injuries
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

active soldiers will perform baseline examinations for the musculoskeletal system. following, an exercise intervention program will be conducted with follow-up examination at the termination of program.