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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862625
• Other study ID #: 2016/72
• Status: Completed
• Phase: N/A
• Start date: April 10, 2016
• Est. completion date: March 2, 2019

Study information

• Verified date: September 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2, 2019
• Est. primary completion date: December 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Neuromuscular Scoliosis
• Paralysis
• Scoliosis

Intervention

Device:
• a modular adaptive seating system

Other:
• home exercise program for scoliosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merve Damla Korkmaz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cobb Angle	cobb angle shows the curvature of the spine in the coronal plane	12 weeks
Primary	Pelvic Obliquity	pelvic obliquity is posture of pelvis in relation to the ground	12 weeks
Primary	Sagittal Balance	sagittal balance of the spine is the posture of the spine on the sagittal plane	12 weeks
Secondary	Reimer's Migration Index (RMI)	it shows the degree of hip subluxation or dislocation	12 weeks