- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469099
Ankle Injuries, Imaging and Prevention Program Effectiveness in New Army Recruits
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Netanya, Israel
- The Academic college Levinsky-Wingate at the Wingate Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- soldiers ages 18-22
Exclusion Criteria:
- knows disease of the bones
- before orthopedic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: research group
active exercises for few weeks
|
exercises for strength and balance
|
|
No Intervention: control
control group - no intervention, continue their routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception ability
Time Frame: baseline, end of intervention
|
Active Movement Extent Discrimination Apparatus AMEDA
|
baseline, end of intervention
|
|
balance
Time Frame: baseline, end of intervention
|
Y balance test
|
baseline, end of intervention
|
|
Leg muscle strength
Time Frame: baseline, end of intervention
|
bilateral heel rise test
|
baseline, end of intervention
|
|
Hip muscle strength
Time Frame: baseline, end of intervention
|
hand held dynamometer
|
baseline, end of intervention
|
|
Ankle agility
Time Frame: baseline, end of intervention
|
hexagon agility hop test
|
baseline, end of intervention
|
|
Ankle stability
Time Frame: baseline, end of intervention
|
Anterior Drawer Test, musculoskeletal ultrasound for the Anterior Talofibular Ligament
|
baseline, end of intervention
|
|
Achilles tendon structure
Time Frame: baseline, end of intervention
|
Ultrasound tissue Characterization for the percentage of fibers types
|
baseline, end of intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gali Dar, Prof., University of Haifa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 231/22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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