The Effect of a Soft Lumbosacral Body Brace Supporting Physiological Lordosis on Postural Control and Walking Speed in Children With Cerebral Palsy (Cerebral palsy)

Kahramanmaraş Sütçü İmam University (KSU)

Status: Enrolling

Conditions: Cerebral Palsy GMFCS-ER I-II

Treatments: Device: soft lumbosacral orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07186036

ethics committee app: 2025/047

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

In our study, a lordosis angle will be created to support the existing lordosis using a steel-balee

Experimental group

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.

Treatment:

Device: soft lumbosacral orthosis