Idiopathic ScoliosisNCT06219772
Assessment of Dynamic Balance in Idiopathic Scoliosis Compared to Normal Subjects
An observational study of Idiopathic Scoliosis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects. Read more about this study
- Who is it for?
- Ages 10 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 31 Aug 2024
- 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 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent idiopathic scoliosis and normal subjects
Who may be able to join
- Females with age between 10-20 years.
- Idiopathic scoliosis will be diagnosed based on clinical examination and radiological measures.
- Cobb's angle will be between 20° and 40°.
- Their BMI from 18 to 24.9 kg/m2.
- They must be willing to participate in the study.
Who cannot join
- History of previous back surgery.
- Neurological deficit.
- Current lower extremity symptoms.
- Symptoms of vertigo or dizziness.
- No other disorders in the vertebral column (disc prolapse, spondylosis, fracture).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dynamic Balance in Females With Adolescent Idiopathic Scoliosis Compared to Normal Subjects: A Comparative Study
The purpose of this study is to assess dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is one of the most common forms of scoliosis. It is a three-dimensional deformity of the spine and trunk with a lateral deviation of ≥ 10°, which can occur during the growing years from 10 years to puberty, with an apparent gender dominance rising with age and severity with a female to male ratio of 1.5:1 to 10:1.
Dynamic balance is the ability to maintain and regain the center of gravity within the base of support in response to outside perturbations or voluntary movements. It has been reported that AIS is associated with trunk imbalance and could negatively influence the sensorimotor control of posture and decrease postural balance capabilities, which increases susceptibility to injuries and impacts the individual's ability to engage in daily living activities.
Previous research reported that postural stability control in adolescents with idiopathic scoliosis is as good as in healthy individuals, and others found that AIS patients have poorer static balance control than age-matched patients without AIS. So the current study will be conducted to investigate the dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.
- Conditions
- Idiopathic Scoliosis
- Keywords
- adolescent idiopathic scoliosis, dynamic balance, Cobb angle, stability index
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
A Biodex balance system will be used for measuring the dynamic balance.
Measured: Through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- King Khalid University
- Responsible party
- Principal investigator, Doaa Ayoub Elimy Mohammed, Cairo University
- Investigators
- Ghada MR Koura, Ass. prof, Study director, King Khalid University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219772
- Sponsor's protocol ID
- ECM#2023-2105
- Status last verified
- Sep 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dynamic Balance in Females With Adolescent Idiopathic Scoliosis Compared to Normal Subjects: A Comparative Study
- ClinicalTrials.gov ID
- NCT06219772
- Acronym / sponsor ID
- ECM#2023-2105
- Conditions
- Idiopathic Scoliosis
- Keywords
- adolescent idiopathic scoliosis, dynamic balance, Cobb angle, stability index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- King Khalid University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Jan 2024 (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.
The purpose of this study is to assess dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.
Detailed description
Adolescent idiopathic scoliosis (AIS) is one of the most common forms of scoliosis. It is a three-dimensional deformity of the spine and trunk with a lateral deviation of ≥ 10°, which can occur during the growing years from 10 years to puberty, with an apparent gender dominance rising with age and severity with a female to male ratio of 1.5:1 to 10:1.
Dynamic balance is the ability to maintain and regain the center of gravity within the base of support in response to outside perturbations or voluntary movements. It has been reported that AIS is associated with trunk imbalance and could negatively influence the sensorimotor control of posture and decrease postural balance capabilities, which increases susceptibility to injuries and impacts the individual's ability to engage in daily living activities.
Previous research reported that postural stability control in adolescents with idiopathic scoliosis is as good as in healthy individuals, and others found that AIS patients have poorer static balance control than age-matched patients without AIS. So the current study will be conducted to investigate the dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent idiopathic scoliosis and normal subjects
Key inclusion criteria (5 listed)
- Females with age between 10-20 years.
- Idiopathic scoliosis will be diagnosed based on clinical examination and radiological measures.
- Cobb's angle will be between 20° and 40°.
- Their BMI from 18 to 24.9 kg/m2.
- They must be willing to participate in the study.
Key exclusion criteria (5 listed)
- History of previous back surgery.
- Neurological deficit.
- Current lower extremity symptoms.
- Symptoms of vertigo or dizziness.
- No other disorders in the vertebral column (disc prolapse, spondylosis, fracture).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic balance
Time frame: Through study completion, an average of 7 months
A Biodex balance system will be used for measuring the dynamic balance.
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 23 Sep 2024.
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Ghada MR Koura, Ass. prof study director
King Khalid University, Saudi Arabia
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 Idiopathic Scoliosis, run by Cairo University 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 5 inclusion and 5 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 23 Sep 2024. 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?
Dynamic balance (time frame: Through study completion, an average of 7 months). 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 23 Sep 2024.