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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06469099
Other study ID # 231/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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