Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
NCT ID: NCT03862625
Last Updated: 2021-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-04-10
2019-03-02
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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a modular adaptive seating system
In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.
a modular adaptive seating system
home exercise program for scoliosis
home exercises for scoliosis
In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis
Interventions
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a modular adaptive seating system
home exercise program for scoliosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
15 Years
ALL
No
Sponsors
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Merve Damla Korkmaz
OTHER
Responsible Party
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Merve Damla Korkmaz
Assistant doctor
Principal Investigators
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Merve D Korkmaz, 1
Role: PRINCIPAL_INVESTIGATOR
Istanbul University
Murat Korkmaz, 2
Role: PRINCIPAL_INVESTIGATOR
Koc University Hospital
Resa Aydın, 3
Role: STUDY_DIRECTOR
Istanbul University
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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2016/72
Identifier Type: -
Identifier Source: org_study_id