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

NCT03862625 | Completed Results DMC

• 1 other identifier: 2016/72
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy; Neuromuscular Scoliosis

Keywords

cerebral palsy; scoliosis; adaptive seating system; sagittal balance; pelvic obliquity; coronal balance

Outcome Measures

Primary Outcomes (3)

• Cobb Angle

  cobb angle shows the curvature of the spine in the coronal plane

  12 weeks

• Pelvic Obliquity

  pelvic obliquity is posture of pelvis in relation to the ground

  12 weeks

• Sagittal Balance

  sagittal balance of the spine is the posture of the spine on the sagittal plane

  12 weeks

Secondary Outcomes (1)

• Reimer's Migration Index (RMI)

  12 weeks

Study Arms (2)

a modular adaptive seating system

EXPERIMENTAL

In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.

Device: a modular adaptive seating system; Other: home exercise program for scoliosis

home exercises for scoliosis

ACTIVE COMPARATOR

In the second group there is only home exercise program for scoliosis.

Other: home exercise program for scoliosis

Interventions

a modular adaptive seating system DEVICE

Also known as: home exercise program for scoliosis

a modular adaptive seating system

home exercise program for scoliosis OTHER

a modular adaptive seating system; home exercises for scoliosis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merve Damla Korkmaz: lead

MeSH Terms

Conditions

Cerebral Palsy; Scoliosis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

First, the participants only in CP with GMCFS level V. Second, the short follow-up period can be counted could be selected as a limitation

Results Point of Contact

• Title: Dr. Merve Damla Korkmaz
• Organization: Istanbul University

mervedml@gmail.com

+905556297264

Study Officials

• Merve D Korkmaz, 1

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Murat Korkmaz, 2

  Koc University Hospital

  PRINCIPAL INVESTIGATOR

• Resa Aydın, 3

  Istanbul University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In our clinical study, the person who performed radiographic evaluations before and after treatment did not know about the treatments received by the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant doctor

Model Details: There are two groups in this study. In the first group, there is home exercises program for scoliosis and a modular adaptive seating system. In the second group there is only home exercises program for scoliosis. The nonambulatory children between the ages of 6-15 with cerebral palsy and scoliosis were randomly grouped according to the order of Pediatric Rehabilitation Unit of Istanbul University, Istanbul Faculty of Medicine, Physical Medicine and Rehabilitation Department.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: April 10, 2016
• Primary Completion: December 2, 2018
• Study Completion: March 2, 2019
• Last Updated: October 20, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: It will be available for sharing after publication.