- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379801
The Musculoskeletal System During Puberty in Dancers With Scoliosis, and the Effect of an Exercise Program
Study Overview
Detailed Description
Objectives: To examine musculoskeletal system characteristics in female dancers with and without scoliosis throughout the pubertal period, and to evaluate the effect of a targeted preventive exercise program.
Methods: Up to 140 female dancers aged 11-16 will be recruited for a two-phase study:
Phase A: a two-year longitudinal study with four assessment time points. . At each time point, participants will complete a comprehensive assessment including: anthropometric measurements (height and weight), sexual maturation status (Tanner scale), scoliosis assessment (Adam's forward bend test, scoliometer measurements, Scoliosis Research Society-22 questionnaire), bone strength (quantitative ultrasound using a Speed of Sound [SOS] device), abdominal and back muscle morphology (ultrasound imaging), hip muscle strength (handheld dynamometry), hip range of motion (goniometry), dynamic balance (Y Balance Test), and flexibility (Beighton score). In addition, participants will complete a demographic questionnaire and an injury surveillance questionnaire.
Phase B : an intervention study in which dancers with scoliosis will be randomly assigned to either a three-month targeted exercise program or a control group continuing regular training. Outcomes will be assessed post-intervention and at one-year follow-up.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gali Dar, PhD
- Phone Number: 972505662054
- Email: gdar@univ.haifa.ac.il
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Haifa University, Department of PHysical Therapy
-
Contact:
- Gali Dar, PhD
- Phone Number: 972-50-5662054
- Email: galidar@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female dancers aged 11-16 years who dance at least three times per week and whose parents have provided informed consent.
- Dancers who have participated in at least three weekly hours of classical ballet during the year preceding the study and during the study year.
- A minimum of two years of experience in classical ballet training.
- Dancers without underlying medical conditions, not taking medications, and with no history of orthopedic surgery.
- dancers diagnosed during the study with mild to moderate scoliosis who are not under medical follow-up requiring active orthopedic or surgical treatment.
Exclusion criteria:
- Dancers who are taking medications, are not in good health, have underlying medical conditions, or have undergone any orthopedic surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: excercise
exercises for strengthening
|
exercise for strengthening core muscles
|
|
No Intervention: control
regular activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ultrasound for muscle thickness
Time Frame: baseline, twice a year for 2 years
|
ultrasound assessment of back and abdominal muscles in rest and contraction - thickness in mm
|
baseline, twice a year for 2 years
|
|
muscle strength test
Time Frame: baseline, twice a year for 2 years
|
hand held dynamometer assessment hip muscles
|
baseline, twice a year for 2 years
|
|
range of motion
Time Frame: baseline, twice a year for 2 years
|
goniometer assessment for lower extremities joints
|
baseline, twice a year for 2 years
|
|
bone strength
Time Frame: baseline, twice a year for 2 years
|
tibia bone strength assessment using Sunlight MiniOmni Ultrasound Bone Sonometer
|
baseline, twice a year for 2 years
|
|
scoliosis
Time Frame: baseline, twice a year for 2 years
|
Adam's tests and scoliometer
|
baseline, twice a year for 2 years
|
|
maturation status
Time Frame: baseline, twice a year for 2 years
|
Tanner scale 0-5 scale.
higher score represent greater maturation status
|
baseline, twice a year for 2 years
|
|
flexibility
Time Frame: baseline, twice a year for 2 years
|
Beighton score.
0-9 scale when higher score represent hyper flexibility
|
baseline, twice a year for 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gali Dar, PhD, University of Haifa
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 034/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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