Scoliosis IdiopathicNCT06812013
Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents
An observational study of Scoliosis Idiopathic, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.
Trial summary
Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis that affects children after the age of 10 years and is considered a critical developmental stage of the musculoskeletal system of the child. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- assessment of foot print and balance
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2025to 8 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study population \& Sample size: One hundred and fifty adolescents will be recruited to participate in the study, seventy-five of them will be healthy adolescents while the other Seventy-five adolescents will have idiopathic scoliosis with different degrees of scoliosis curves.
Who may be able to join
- 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°
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis that affects children after the age of 10 years and is considered a critical developmental stage of the musculoskeletal system of the child. AIS causes deviations in the CNS, leading to asymmetry of motor activity and, consequently, an incorrect position of the spine. The progressive deformation of the spine leads to increased asymmetry in body functions. This elevated asymmetry is understood by the nervous system as a norm, which causes children to cease to sense the correct body position that may affect both static and dynamic balance and the foot pressure symmetry of the child, which was not investigated in such cases in any previous studies till now.
- Conditions
- Scoliosis Idiopathic
- Being tested
- assessment of foot print and balance
- Keywords
- foot print, scoliosis, balance
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of foot print and balanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy adolescents | healthy adolescents Receives: Other: assessment of foot print and balance | |
| study group | adolescents with scoliosis Receives: Other: assessment of foot print and balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
static and dynamic balance
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.
Measured: 2 months
foot print
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start10 Feb 2025
- Primary completion5 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812013
- Sponsor's protocol ID
- Scoliosis
- Status last verified
- May 2025
- First submitted
- 13 Jan 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents
- ClinicalTrials.gov ID
- NCT06812013
- Acronym / sponsor ID
- Scoliosis
- Conditions
- Scoliosis Idiopathic
- Keywords
- foot print, scoliosis, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis that affects children after the age of 10 years and is considered a critical developmental stage of the musculoskeletal system of the child. AIS causes deviations in the CNS, leading to asymmetry of motor activity and, consequently, an incorrect position of the spine. The progressive deformation of the spine leads to increased asymmetry in body functions. This elevated asymmetry is understood by the nervous system as a norm, which causes children to cease to sense the correct body position that may affect both static and dynamic balance and the foot pressure symmetry of the child, which was not investigated in such cases in any previous studies till now.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy adolescents | – | Other: assessment of foot print and balancehealthy adolescents |
| study group | – | Other: assessment of foot print and balanceadolescents with scoliosis |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population \& Sample size: One hundred and fifty adolescents will be recruited to participate in the study, seventy-five of them will be healthy adolescents while the other Seventy-five adolescents will have idiopathic scoliosis with different degrees of scoliosis curves.
Key inclusion criteria (3 listed)
- 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°
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of foot print and balanceFor 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. | Other | healthy adolescents, study group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static and dynamic balance (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.