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NCT Number: NCT07186036

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

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, onikişubat, 46100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Asiya Uzun Asisstant Proffesor

CONTACT

[email protected]

+90(344) 300-2621

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soft lumbosacral orthosis

Device

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

Primary outcomes

  1. Functional Reach Test

    Time frame: The first day of assesment

    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).

  2. Seated Postural Control Measurement (SPCM)

    Time frame: The first day of assesment

    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.

  3. Paediatric Berg Balance Test

    Time frame: the first day of assesment

    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.

  4. Timed Up and Go Test (TUG)

    Time frame: the first day of assesment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Asiya Uzun Assistant Proffesor

CONTACT

[email protected]

+90(344) 300-2621

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Acronym: Cerebral palsy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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