- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812013
Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Modern University for Technology and Information
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Asymptomatic children and adolescents ages 10 to 18 years
- confirmed through X-rays; we focused on patients in growing age.
- adolescent idiopathic scoliosis that has a Cobb angle of 10° to 50°
Exclusion Criteria:
- Neuromuscular etiology (e.g., cerebral palsy, myelomeningocele, muscular dystrophy, spinal muscular atrophy, spina bifida, spinal cord injuries)
- Early-onset idiopathic etiology (infantile [ages 0 to 3 years] or juvenile [ages 4 to 9 years])
- Congenital etiology (e.g., hemivertebrae, failure of segmentation) Mesenchymal/syndromic etiology (e.g., Marfan syndrome, mucopolysaccharidosis, osteogenesis imperfecta, inflammatory diseases, postoperative)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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healthy adolescents
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For static and dynamic balance assessment, Biodex Medical Systems Inc., Shirley, New York, USA (serial n.: 13020193) was used. The device consists of a circular foot platform that permits tilting in all directions, height-adjustable support rails, height adjustable display screen, and a printer. Balance assessment by the Biodex system is a valid and reliable objective measurement. For assessment of foot print symmetry Tekscan HR walkway Mat™ pressure measurement system, Tekscan Inc. USA will be use. It is made up of a digital mat inserted into a wooden walkway, sensors (4 senses/cm2) embedded in the mat, and a computer running the Tekscan Software (version 7) for data extrapolation. |
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study group
adolescents with scoliosis
|
For static and dynamic balance assessment, Biodex Medical Systems Inc., Shirley, New York, USA (serial n.: 13020193) was used. The device consists of a circular foot platform that permits tilting in all directions, height-adjustable support rails, height adjustable display screen, and a printer. Balance assessment by the Biodex system is a valid and reliable objective measurement. For assessment of foot print symmetry Tekscan HR walkway Mat™ pressure measurement system, Tekscan Inc. USA will be use. It is made up of a digital mat inserted into a wooden walkway, sensors (4 senses/cm2) embedded in the mat, and a computer running the Tekscan Software (version 7) for data extrapolation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
static and dynamic balance
Time Frame: 2 months
|
For static and dynamic balance assessment, Biodex Medical Systems Inc., Shirley, New York, USA (serial n.: 13020193) was used.
The device consists of a circular foot platform that permits tilting in all directions, height-adjustable support rails, height adjustable display screen, and a printer.
Balance assessment by the Biodex system is a valid and reliable objective measurement.
|
2 months
|
|
foot print
Time Frame: 2 months
|
For assessment of foot print symmetry Tekscan HR walkway Mat™ pressure measurement system, Tekscan Inc. USA will be use.
It is made up of a digital mat inserted into a wooden walkway, sensors (4 senses/cm2) embedded in the mat, and a computer running the Tekscan Software (version 7) for data extrapolation.
|
2 months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Scoliosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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