Idiopathic ScoliosisNCT06290843
Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Schroth method
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 23 Apr 2024to 30 May 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 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: children aged 11-18 years diagnosed with adolescent idiopathic scoliosis
Who may be able to join
- Idiopathic adolescent scoliosis aged 10-18 years, female,
- control group aged 10-18 years, female.
Who cannot join
- congenital spine defects,
- spine surgeries,
- neurological diseases,
- cardiological diseases,
- genetic diseases,
- rheumatological diseases,
Show all 11Show fewer
- immunological diseases,
- endocrine diseases
- back pain,
- lower limb pain,
- past injuries of lower limbs or spine
Trial locations and contacts
1 site in 1 country.
Poland1 site
Gdansk University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group.
Read the detailed description
Assessment of balance parameters on the AMTI dynanometric platform in children with adolescent idiopathic scoliosis and healthy children in the same age group. Each person examined will have one trial measurement, followed by a 3-minute break. After the trial measurement, the actual examination will take place - 3 trials of 60 seconds each in 4 different variants: eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.The variants will be randomized.
Assessment of body posture using photo recordings taken with an OLYMPUS digital camera, which will be used to classify the type of scoliosis. Anthropometric points will be marked using a washable marker: cervical-thoracic junction C7-Th1, thoracic-lumbar junction Th12/L1, lumbosacral junction L5/S1, right and left anterior superior iliac spine (ASIS), right and left posterior superior iliac spine ( PSIS), the center of the right and left greater trochanters and the center of the lateral malleolus. Photo registration will be made in four positions: front, back, right side and left side. The camera is 3 m away from the subject and the height of the tripod is half the height of the body.
Analysis of spine X-ray images: Cobb angle, Schroth type of scoliosis, Bordering vertebrae, Apex vertebra, Vertebral rotation, Sagittal plane analysis
- Conditions
- Idiopathic Scoliosis
- Being tested
- Schroth method
- Keywords
- Spinal deformity, AMTI platform, Balance, Postural stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth methodProcedure or surgery
Exercises from Schoth method
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis | Children with idiopathic scoliosis Receives: Procedure: Schroth method | |
| Control | Children without idiopathic scoliosis Receives: Procedure: Schroth method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of body balance on the AMTI force platform
The measurement of center of pressure (anterior-posterior) (cm) in standing position with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Measured: Before and after 12-week therapy
Analysis of body balance on the AMTI force platform
Center of pressure (medial-lateral) (cm) in standing position with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Measured: Before and after 12-week therapy
Analysis of body balance on the AMTI force platform
Velocity (m/s) of center of pressure changes with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Measured: Directly before and after 12-week therapy
Analysis of body balance on the AMTI force platform
Sway area (cm2) of center of pressure with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Measured: Directly before and after 12-week therapy
Photographic analysis of body posture
The photos will be taken in various positions: front, back and both sides.
Measured: Directly before and after 12-week therapy
Analysis of x-ray in the frontal plane
Cobb angle (degree)
Measured: One-time examintation before therapy
Analysis of x-ray in the frontal plane
Bordering vertebrae (no.)
Measured: One-time examintation before therapy
Analysis of x-ray in the frontal plane
Apex vertebra (no.)
Measured: One-time examintation before therapy
Analysis of x-ray in the frontal plane
Vertebral rotation (degree)
Measured: One-time examintation before therapy
Analysis of x-ray in the sagittal plane
Kyphosis angle (degree)
Measured: One-time examintation before therapy
Analysis of x-ray in the sagittal plane
Lordosis angle (degree)
Measured: One-time examintation before therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start23 Apr 2024
- Primary completion30 May 2024
- Study completion30 May 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.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina Ewertowska, Principal investigator, Akademia Wychowania Fizycznego i Sportu w Gdańsku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290843
- Sponsor's protocol ID
- AWFiS/2024_1_PE
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06290843
- Acronym / sponsor ID
- AWFiS/2024_1_PE
- Conditions
- Idiopathic Scoliosis
- Keywords
- Spinal deformity, AMTI platform, Balance, Postural stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 4 Mar 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 aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group.
Detailed description
Assessment of balance parameters on the AMTI dynanometric platform in children with adolescent idiopathic scoliosis and healthy children in the same age group. Each person examined will have one trial measurement, followed by a 3-minute break. After the trial measurement, the actual examination will take place - 3 trials of 60 seconds each in 4 different variants: eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.The variants will be randomized.
Assessment of body posture using photo recordings taken with an OLYMPUS digital camera, which will be used to classify the type of scoliosis. Anthropometric points will be marked using a washable marker: cervical-thoracic junction C7-Th1, thoracic-lumbar junction Th12/L1, lumbosacral junction L5/S1, right and left anterior superior iliac spine (ASIS), right and left posterior superior iliac spine ( PSIS), the center of the right and left greater trochanters and the center of the lateral malleolus. Photo registration will be made in four positions: front, back, right side and left side. The camera is 3 m away from the subject and the height of the tripod is half the height of the body.
Analysis of spine X-ray images: Cobb angle, Schroth type of scoliosis, Bordering vertebrae, Apex vertebra, Vertebral rotation, Sagittal plane analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis | – | Procedure: Schroth methodChildren with idiopathic scoliosis |
| Control | – | Procedure: Schroth methodChildren without idiopathic scoliosis |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children aged 11-18 years diagnosed with adolescent idiopathic scoliosis
Key inclusion criteria (2 listed)
- Idiopathic adolescent scoliosis aged 10-18 years, female,
- control group aged 10-18 years, female.
Key exclusion criteria (11 listed)
- congenital spine defects,
- spine surgeries,
- neurological diseases,
- cardiological diseases,
- genetic diseases,
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 |
|---|---|---|
| Schroth methodExercises from Schoth method | Procedure or surgery | Control, Scoliosis |
Primary outcome
Analysis of body balance on the AMTI force platform
Time frame: Before and after 12-week therapy
The measurement of center of pressure (anterior-posterior) (cm) in standing position with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Analysis of body balance on the AMTI force platform
Time frame: Before and after 12-week therapy
Center of pressure (medial-lateral) (cm) in standing position with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Analysis of body balance on the AMTI force platform
Time frame: Directly before and after 12-week therapy
Velocity (m/s) of center of pressure changes with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Analysis of body balance on the AMTI force platform
Time frame: Directly before and after 12-week therapy
Sway area (cm2) of center of pressure with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
Photographic analysis of body posture
Time frame: Directly before and after 12-week therapy
The photos will be taken in various positions: front, back and both sides.
Analysis of x-ray in the frontal plane
Time frame: One-time examintation before therapy
Cobb angle (degree)
Analysis of x-ray in the frontal plane
Time frame: One-time examintation before therapy
Bordering vertebrae (no.)
Analysis of x-ray in the frontal plane
Time frame: One-time examintation before therapy
Apex vertebra (no.)
Analysis of x-ray in the frontal plane
Time frame: One-time examintation before therapy
Vertebral rotation (degree)
Analysis of x-ray in the sagittal plane
Time frame: One-time examintation before therapy
Kyphosis angle (degree)
Analysis of x-ray in the sagittal plane
Time frame: One-time examintation before therapy
Lordosis angle (degree)
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 31 Oct 2024.
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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.
Paulina Ewertowska principal investigator
Akademia Wychowania Fizycznego i Sportu w Gdańsku
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 Gdansk University of Physical Education and Sport at 1 site in Poland.
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 2 inclusion and 11 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 31 Oct 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 Poland. 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?
Analysis of body balance on the AMTI force platform (time frame: Before and after 12-week therapy). The study lists 11 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 31 Oct 2024.