The Effect of a Soft Lumbosacral Body Brace Supporting Physiological Lordosis on Postural Control and Walking Speed in Children With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: soft lumbosacral orthosis.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy GMFCS-ER I-II. Basic parameters: 6 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device soft lumbosacral orthosis
The effect of trunk corsets on postural control and walking, GYA independence
Primary outcome measures
- Functional Reach Test [Time frame: The first day of assesment]
- Seated Postural Control Measurement (SPCM) [Time frame: The first day of assesment]
- Paediatric Berg Balance Test [Time frame: the first day of assesment]
- Timed Up and Go Test (TUG) [Time frame: the first day of assesment]
Eligibility criteria
Inclusion Criteria:Children with cerebral palsy
- Aged 6-15 years
- GMFCS 1-2
- Voluntarily participating in the study
Exclusion Criteria:Children with cerebral palsy
- Inappropriate GMFCS level
- Presence of orthopaedic problems that may affect balance
- Lack of cooperation from the individual
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Kahramanmaraş Sütçü İmam Üniversitesi — Kahramanmaraş
Identifiers
NCT: NCT07186036 · ethics committee app: 2025/047