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

Primary Purpose

Cerebral Palsy, Neuromuscular Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a modular adaptive seating system
home exercise program for scoliosis
Sponsored by
Merve Damla Korkmaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, scoliosis, adaptive seating system, sagittal balance, pelvic obliquity, coronal balance

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    a modular adaptive seating system

    home exercises for scoliosis

    Arm Description

    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 exercise program for scoliosis.

    Outcomes

    Primary Outcome Measures

    Cobb Angle
    cobb angle shows the curvature of the spine in the coronal plane
    Pelvic Obliquity
    pelvic obliquity is posture of pelvis in relation to the ground
    Sagittal Balance
    sagittal balance of the spine is the posture of the spine on the sagittal plane

    Secondary Outcome Measures

    Reimer's Migration Index (RMI)
    it shows the degree of hip subluxation or dislocation

    Full Information

    First Posted
    February 27, 2019
    Last Updated
    September 24, 2021
    Sponsor
    Merve Damla Korkmaz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03862625
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 10, 2016 (Actual)
    Primary Completion Date
    December 2, 2018 (Actual)
    Study Completion Date
    March 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Merve Damla Korkmaz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Neuromuscular Scoliosis
    Keywords
    cerebral palsy, scoliosis, adaptive seating system, sagittal balance, pelvic obliquity, coronal balance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Outcomes Assessor
    Masking Description
    In our clinical study, the person who performed radiographic evaluations before and after treatment did not know about the treatments received by the participants.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    a modular adaptive seating system
    Arm Type
    Experimental
    Arm Description
    In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.
    Arm Title
    home exercises for scoliosis
    Arm Type
    Active Comparator
    Arm Description
    In the second group there is only home exercise program for scoliosis.
    Intervention Type
    Device
    Intervention Name(s)
    a modular adaptive seating system
    Other Intervention Name(s)
    home exercise program for scoliosis
    Intervention Type
    Other
    Intervention Name(s)
    home exercise program for scoliosis
    Primary Outcome Measure Information:
    Title
    Cobb Angle
    Description
    cobb angle shows the curvature of the spine in the coronal plane
    Time Frame
    12 weeks
    Title
    Pelvic Obliquity
    Description
    pelvic obliquity is posture of pelvis in relation to the ground
    Time Frame
    12 weeks
    Title
    Sagittal Balance
    Description
    sagittal balance of the spine is the posture of the spine on the sagittal plane
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Reimer's Migration Index (RMI)
    Description
    it shows the degree of hip subluxation or dislocation
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merve D Korkmaz, 1
    Organizational Affiliation
    Istanbul University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Murat Korkmaz, 2
    Organizational Affiliation
    Koc University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Resa Aydın, 3
    Organizational Affiliation
    Istanbul University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    It will be available for sharing after publication.

    Learn more about this trial

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

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