N/A
N=30
Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
Cerebral Palsy · Neuromuscular Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT03862625 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Cobb Angle — 23.77; 26.31 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- a modular adaptive seating system (Device); home exercise program for scoliosis (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Merve Damla Korkmaz
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cobb Angle |
23.77; 26.31 | — |
| PRIMARY Pelvic Obliquity |
6.46; 7.39 | — |
| PRIMARY Sagittal Balance |
33.75; 41.07; 36.25; 36.16; 20.99; 13.37 | — |
| SECONDARY Reimer's Migration Index (RMI) |
26.27; 22.85; 39.80; 32.43 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03862625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.