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

Ankle Sprains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06469099
• Other study ID #: 231/22
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: September 15, 2026

Study information

• Verified date: June 2024
• Source: University of Haifa
• Contact: Gali Dar, Prof
• Phone: 0505662054
• Email: galidar[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

infantry recruits will be examined - for the musculoskeletal system status (tendon, muscle, proprioception, agility, joints) Following, intervention program of exercises will be conducted. Another evaluation will be performed at the end of the intervention.

Description:

Purpose: to assess characteristics of ankle injuries in new infantry recruits, the association with imaging and functional measures, and evaluate preventative 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 at the end of the training (after approximately six months), the soldiers will be assessed for: 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 will be diagnosed with a sprain will be evaluated with an ultrasound, that will be performed at the base every few weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 22 Years

Eligibility

Inclusion Criteria:

• soldiers ages 18-22

Exclusion Criteria:

• knows disease of the bones

• before orthopedic surgery

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

Other:
• excercises
exercises for strength and balance

Locations

Country	Name	City	State
Israel	The Academic college Levinsky-Wingate at the Wingate Institute	Netanya

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Zinman College of Physical Education and Sports Sciences

Country where clinical trial is conducted

Israel, 

Outcome

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