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

NCT ID: NCT07186036

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy GMFCS-ER I-II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

soft lumbosacral orthosis

Intervention Type DEVICE

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

Interventions

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soft lumbosacral orthosis

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Inappropriate GMFCS level
* Presence of orthopaedic problems that may affect balance
* Lack of cooperation from the individual
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Asiya Uzun

Assistant Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, onikişubat, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Asiya Uzun Assistant Proffesor

Role: CONTACT

+90(344) 300-2621

Facility Contacts

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Asiya Uzun Asisstant Proffesor

Role: primary

+90(344) 300-2621

Other Identifiers

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ethics committee app: 2025/047

Identifier Type: -

Identifier Source: org_study_id

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