NCT03862625

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merve Damla Korkmaz · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cerebral Palsy
• Neuromuscular Scoliosis

Interventions

Type	Name	Description
DEVICE	a modular adaptive seating system
OTHER	home exercise program for scoliosis

Timeline

• Start date: 2016-04-10
• Primary completion: 2018-12-02
• Completion: 2019-03-02
• First posted: 2019-03-05
• Last updated: 2021-10-20
• Results posted: 2021-02-02