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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318325
Other study ID # ADINEGEV-2021_102
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date March 15, 2026

Study information

Verified date April 2024
Source University of Haifa
Contact Gali Dar, Prof
Phone 0505662054
Email galidar@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

assessment of the musculoskeletal system will be performed twice a year, for three years of young gymnasts.


Description:

Aims: To examine the changes in the anatomical and morphological features in the skeleton of young female artistic and rhythmic gymnasts and follow the risk of injuries during the period of pubertal growth. Methods: 200 gymnasts (100 rhythmic and 100 artistic) will participate. Measurements will be performed at the beginning and the end of each year, for three years. Each gymnast will be examined for the following: asked about her menarche, assessed by a physician for Tanner stages, and will answer the Triad-specific self-report questionnaire. Anthropometric measurements (height, weight, BMI), muscle strength (using hand-held dynamometer), joint range of motion (using goniometer), scoliosis, and Beighton test for hypermobility will be assessed. In addition, the gymnasts will be scanned by using three different ultrasounds: Bone age for the skeletal age, SOS for the bone properties, and ultrasound tissue characterization for the tendon structure. The gymnasts will be asked about their physical training history, frequency, and training intensity. Each gymnast will be asked whether she had pain or injuries during the period she has been training, as well as a physical and injuries evaluation that will be conducted by a physician. Once a month a telephone follow-up with the trainer regarding any pain or injuries in the last month will be conducted.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 15, 2026
Est. primary completion date March 15, 2026
Accepts healthy volunteers
Gender Female
Age group 9 Years to 16 Years
Eligibility Inclusion Criteria: - training at least 4 times per week, - a minimum of 16 hours per week, at a competitive level. - The gymnasts exercised fully three months before the beginning of the study - have not been absent more than three days from training due to pain, discomfort, or injury. Exclusion Criteria: - present injury causing pain - missing training.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
examination
examination of tendon, muscle joints and injuries

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Haifa The Academic college Levinsky-Wingate at the Wingate Institute, Netanya, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary ultrasound tissue characterized percentage of type 1,2,3,4 fibers within the tendon baseline, twice a year for 3 years
Primary muscle strength test hand held dynamometer assessment of ankle, knee and hip muscles baseline, twice a year for 3 years
Primary range of motion goniometer assessment for lower extremities joints baseline, twice a year for 3 years
Primary bone strength tibia bone strength assessment using Sunlight MiniOmni Ultrasound Bone Sonometer baseline, twice a year for 3 years
Primary Bone Age bone age of the radius bone using ultrasound for bone age baseline, twice a year for 3 years
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