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

NCT07186036 | Recruiting

• 1 other identifier: ethics committee app: 2025/047
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

cerebral palsy,; walking; postur; postural control

Outcome Measures

Primary Outcomes (4)

• Functional Reach Test

  Developed by Duncan et al. 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).

  The first day of assesment

• 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.

  The first day of assesment

• Paediatric Berg Balance Test

  The Paediatric Berg Balance Scale (PBBS), a version of the Berg Balance Scale adapted for children by Franjoine and colleagues, 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.

  the first day of assesment

• Timed Up and Go Test (TUG)

  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.

  the first day of assesment

Study Arms (1)

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.

Device: soft lumbosacral orthosis

Interventions

soft lumbosacral orthosis DEVICE

The effect of trunk corsets on postural control and walking, GYA independence

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

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6-15 years
• GMFCS 1-2
• Voluntarily participating in the study

You may not qualify if:

• Inappropriate GMFCS level
• Presence of orthopaedic problems that may affect balance
• Lack of cooperation from the individual

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, onikişubat, 46100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Asiya Uzun Assistant Proffesor

CONTACT

+90(344) 300-2621; asiyauzun@ksu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Model Details: 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 Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: June 15, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)