Clinical trial NCT03862625: Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Neuromuscular Scoliosis
Keywords: cerebral palsy
scoliosis
adaptive seating system
sagittal balance
pelvic obliquity
coronal balance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cobb Angle
timeFrame: 12 weeks
measure: Pelvic Obliquity
timeFrame: 12 weeks
measure: Sagittal Balance
timeFrame: 12 weeks
Secondary outcomes:
measure: Reimer's Migration Index (RMI)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Merve D Korkmaz, 1
role: PRINCIPAL_INVESTIGATOR
affiliation: Koc University Hospital
name: Murat Korkmaz, 2
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Resa Aydın, 3
role: STUDY_DIRECTOR
References: