Cerebral Palsy GMFCS-ER I-IICerebral palsyNCT07186036
The Effect of a Soft Lumbosacral Body Brace Supporting Physiological Lordosis on Postural Control and Walking Speed in Children With Cerebral Palsy
A study testing soft lumbosacral orthosis in people with Cerebral Palsy GMFCS-ER I-II, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of soft lumbosacral body braces on postural control and walking speed in children with cerebral palsy. Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy improve postural control. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy GMFCS-ER I-II
- What is being tested?
- soft lumbosacral orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-15 years
- GMFCS 1-2
- Voluntarily participating in the study
Who cannot join
- Inappropriate GMFCS level
- Presence of orthopaedic problems that may affect balance
- Lack of cooperation from the individual
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam Üniversitesi
Kahramanmaraş, onikişubat, 46100
About this study
The aim of this study is to investigate the effect of soft lumbosacral body braces on postural control and walking speed in children with cerebral palsy.
Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy improve postural control. Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy correct posture. Hypothesis 2: A soft lumbosacral body corset increases walking speed in children with cerebral palsy.
The number of individuals to be included in the study has been determined using G*Power 3.1.9.7 effect size: 0.80, α = 0.05, power: 0.95. Individuals with CP who attend specific rehabilitation centres in Gaziantep and Kahramanmaraş and have GMFCS levels 1 and 2 will be included in the study. The necessary permissions will be obtained from the centres. The demographic information, clinical levels, and clinical types of the individuals will be recorded using a form. The Postural Control Measurement in Sitting, Paediatric Berg Balance Test, and Functional Reach Test will be used to assess the postural control of children with SP. Walking speed will be assessed using the Timed Up and Go Test. In our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis.
- Conditions
- Cerebral Palsy GMFCS-ER I-II
- Being tested
- soft lumbosacral orthosis
- Keywords
- cerebral palsy,, walking, postur, postural control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft lumbosacral orthosisDevice
The effect of trunk corsets on postural control and walking, GYA independence
| Study group | Role | What they receive |
|---|---|---|
| In our study, a lordosis angle will be created to support the existing lordosis using a steel-balee | Experimental | In our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis. Receives: Device: soft lumbosacral orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Reach Test
Developed in 1990 to assess dynamic balance. The maximum distance reached forward with the arm without disrupting the fixed standing position is measured. The distance between the third metacarpals is measured at the start and end positions of the test. The subject is asked to reach forward three times, and the average is taken. It is valid and reliable for children with SP (ICC = 0.94, 0.97, 0.98).
Measured: First day
Seated Postural Control Measurement (SPCM)
Developed by a team of occupational therapists and physiotherapists at Sunny Hill Health Centre in Vancouver, Canada, to assess seated posture. SPCM evaluates the child's postural impairment as well as the effect of sitting on postural control.
Measured: First day
Paediatric Berg Balance Test
The Paediatric Berg Balance Scale (PBBS), a version of the Berg Balance Scale adapted for children, will be used to assess functional balance in daily living activities. The scale consists of 14 items, each scored from 0 to 4, with a maximum possible score of 56.
Measured: First day
Timed Up and Go Test
Used to assess functional mobility and dynamic balance. The TUG is a valid and reliable test for assessing balance in children with cerebral palsy (r=0.99). A chair with a backrest but no armrests is used for the assessment. The test begins with the child sitting on the chair with their hips and knees flexed at 90°. The child is asked to stand up from the chair, walk 3 metres, and sit back down. The time taken from standing up from the chair to sitting back down is recorded. The test is repeated 3 times, and the average of these three values is taken for analysis.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Jun 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy GMFCS-ER I-IIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asiya Uzun, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186036
- Sponsor's protocol ID
- ethics committee app: 2025/047
- Acronym
- Cerebral palsy
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Soft Lumbosacral Body Brace Supporting Physiological Lordosis on Postural Control and Walking Speed in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07186036
- Acronym / sponsor ID
- Cerebral palsy / ethics committee app: 2025/047
- Conditions
- Cerebral Palsy GMFCS-ER I-II
- Keywords
- cerebral palsy,, walking, postur, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 22 Sep 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.
The aim of this study is to investigate the effect of soft lumbosacral body braces on postural control and walking speed in children with cerebral palsy.
Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy improve postural control. Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy correct posture. Hypothesis 2: A soft lumbosacral body corset increases walking speed in children with cerebral palsy.
The number of individuals to be included in the study has been determined using G*Power 3.1.9.7 effect size: 0.80, α = 0.05, power: 0.95. Individuals with CP who attend specific rehabilitation centres in Gaziantep and Kahramanmaraş and have GMFCS levels 1 and 2 will be included in the study. The necessary permissions will be obtained from the centres. The demographic information, clinical levels, and clinical types of the individuals will be recorded using a form. The Postural Control Measurement in Sitting, Paediatric Berg Balance Test, and Functional Reach Test will be used to assess the postural control of children with SP. Walking speed will be assessed using the Timed Up and Go Test. In our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis.
| Arm | Type | Receives |
|---|---|---|
| In our study, a lordosis angle will be created to support the existing lordosis using a steel-balee | Experimental | Device: soft lumbosacral orthosisIn our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 6-15 years
- GMFCS 1-2
- Voluntarily participating in the study
Key exclusion criteria (3 listed)
- Inappropriate GMFCS level
- Presence of orthopaedic problems that may affect balance
- Lack of cooperation from the individual
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 |
|---|---|---|
| soft lumbosacral orthosisThe effect of trunk corsets on postural control and walking, GYA independence | Device | In our study, a lordosis angle will be created to support the existing lordosis using a steel-balee |
Primary outcome
Functional Reach Test
Time frame: First day
Developed in 1990 to assess dynamic balance. The maximum distance reached forward with the arm without disrupting the fixed standing position is measured. The distance between the third metacarpals is measured at the start and end positions of the test. The subject is asked to reach forward three times, and the average is taken. It is valid and reliable for children with SP (ICC = 0.94, 0.97, 0.98).
Seated Postural Control Measurement (SPCM)
Time frame: First day
Developed by a team of occupational therapists and physiotherapists at Sunny Hill Health Centre in Vancouver, Canada, to assess seated posture. SPCM evaluates the child's postural impairment as well as the effect of sitting on postural control.
Paediatric Berg Balance Test
Time frame: First day
The Paediatric Berg Balance Scale (PBBS), a version of the Berg Balance Scale adapted for children, will be used to assess functional balance in daily living activities. The scale consists of 14 items, each scored from 0 to 4, with a maximum possible score of 56.
Timed Up and Go Test
Time frame: First day
Used to assess functional mobility and dynamic balance. The TUG is a valid and reliable test for assessing balance in children with cerebral palsy (r=0.99). A chair with a backrest but no armrests is used for the assessment. The test begins with the child sitting on the chair with their hips and knees flexed at 90°. The child is asked to stand up from the chair, walk 3 metres, and sit back down. The time taken from standing up from the chair to sitting back down is recorded. The test is repeated 3 times, and the average of these three values is taken for analysis.
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 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy GMFCS-ER I-II
Recruiting
Exercise Training Among Children With Cerebral Palsy to Increase Health and Well-being - A Feasibility Study
Children With Cerebral Palsy Who Are Ambulant, Cerebral Palsy GMFCS-ER I-II
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?
A study testing soft lumbosacral orthosis in people with Cerebral Palsy GMFCS-ER I-II, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 2 Nov 2026. 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 Turkey (Türkiye). 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?
Functional Reach Test (time frame: First day). The study lists 4 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 2 Nov 2026.