Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial

September 24, 2021 updated by: Merve Damla Korkmaz

The Effect of a New-designed Modular Adaptive Seating System on Coronal and Sagittal Balance of the Spine and Pelvic Obliquity in Children With Nonambulatory Cerebral Palsy and Scoliosis

The effect of a modular seating system on coronal and sagittal balance of the spine and pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System Level IV-V) and scoliosis

The hypothesis in our study is; a modular adaptive seating system prevents the progression of spinal curvature and Reimer's maturation index, improves the sagittal balance of the spine and pelvic obliquity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study was to evaluate the effect of a modular adaptive seating system and exercise therapy for scoliosis on the progression of spinal curvature, spinal sagittal balance and pelvic obliquity in children aged 6 to 15 years with cerebral palsy (Gross Motor Function Classification System (GMFCS) level IV-V) and scoliosis.

Materials and methods: A prospective, randomized and controlled, single-blind study was performed on 29 patients with cerebral palsy(CP). Patients were randomized into two groups. Both groups were given scoliosis home exercise program at least three days a week and 10 repetitions for each exercise in a day. In the first group, a modular adaptive seating system used for at least four hours in a day with exercise program for scoliosis. This seating system includes a sitting elevation that corrects the pelvic obliquity, the hip block that prevents the sliding from the sitting floor and a body support unit that provides the alignment of the spine and controls of the body. Cobb angle, pelvic obliquity, sagittal spino-pelvic parameters (thoracic kyphosis angle (TK), lumbar lordosis angle (LL), sagittal vertical axis (SVA), pelvic tilt (PT), pelvic incidence (PI), sacral slop (SS)) and Reimer's migration index (RMI) measurements were evaluated by Surgimap® software at the before and 3 months after treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the participant 6 to 15 years of age during inclusion
  • the participant is diagnosed as cerebral palsy by a specialist
  • the participant's Cobb angle is between 10-40 degrees. (Cobb angle above 40 degrees and patients whose parents have not accepted the operation)
  • There is no history of operation due to scoliosis or the decision of the operation has not been accepted by the patients and their parents
  • the participant is Gross Motor Function Classification System Level 4 or 5
  • Lack of contracture to prevent sitting in the lower extremity
  • Parents agree to participate in the intensive therapy program and stop the therapeutic interventions for scoliosis and lower extremities during the 3-month follow-up period

Exclusion Criteria:

  • Having a history of operation due to scoliosis
  • The deformity in the spine is rigid
  • If the curvature measured in the spine is less than 10 degrees or more than 40 degrees in the patients whose operation decision is accepted by the family
  • Having a seating modification applied at least 1 year before being included in the study
  • Having a spasticity and contracture to prevent sitting in the hip and knee joint
  • Having a pressure ulcer to prevent the patient from sitting
  • the participant has comorbidity that is not related about cerebral palsy
  • Having epileptic seizures not controlled
  • Having bone operations for hip joints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a modular adaptive seating system
In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.
Device: a modular adaptive seating system
Other Names:
  • home exercise program for scoliosis
Other: home exercise program for scoliosis
Active Comparator: home exercises for scoliosis
In the second group there is only home exercise program for scoliosis.
Other: home exercise program for scoliosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb Angle
Time Frame: 12 weeks
cobb angle shows the curvature of the spine in the coronal plane
12 weeks
Pelvic Obliquity
Time Frame: 12 weeks
pelvic obliquity is posture of pelvis in relation to the ground
12 weeks
Sagittal Balance
Time Frame: 12 weeks
sagittal balance of the spine is the posture of the spine on the sagittal plane
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reimer's Migration Index (RMI)
Time Frame: 12 weeks
it shows the degree of hip subluxation or dislocation
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merve Damla Korkmaz

Investigators

  • Principal Investigator: Merve D Korkmaz, 1, Istanbul University
  • Principal Investigator: Murat Korkmaz, 2, Koc University Hospital
  • Study Director: Resa Aydın, 3, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2016

Primary Completion (Actual)

December 2, 2018

Study Completion (Actual)

March 2, 2019

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

March 2, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

It will be available for sharing after publication.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on a modular adaptive seating system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe