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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a modular adaptive seating system | Experimental | In the first group, there is home exercises program for scoliosis and a modular adaptive seating system. |
|
| home exercises for scoliosis | Active Comparator | In the second group there is only home exercise program for scoliosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a modular adaptive seating system | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Cobb Angle | cobb angle shows the curvature of the spine in the coronal plane | 12 weeks |
| Pelvic Obliquity | pelvic obliquity is posture of pelvis in relation to the ground | 12 weeks |
| Sagittal Balance | sagittal balance of the spine is the posture of the spine on the sagittal plane | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reimer's Migration Index (RMI) | it shows the degree of hip subluxation or dislocation | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merve D Korkmaz, 1 | Istanbul University | Principal Investigator |
| Murat Korkmaz, 2 | Koc University Hospital | Principal Investigator |
| Resa Aydın, 3 | Istanbul University | Study Director |
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It will be available for sharing after publication.
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30 nonambulatory children aged 6-15 years with CP and scoliosis who were admitted to Istanbul University, Istanbul Medical Faculty, Pediatric Rehabilitation Unit of the Department of Physical Medicine and Rehabilitation were included in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Home Exercises for Scoliosis | In the second group there is only home exercise program for scoliosis. home exercise program for scoliosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Home Exercises for Scoliosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cobb Angle | cobb angle shows the curvature of the spine in the coronal plane | Posted | Mean | Standard Deviation | degrees | 12 weeks |
|
12 week-period
The participants has been controlled for advers events. These are pressure ulsers on sitting surfaces and pain at the spinal muscles.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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First, the participants only in CP with GMCFS level V. Second, the short follow-up period can be counted could be selected as a limitation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Merve Damla Korkmaz | Istanbul University | +905556297264 | mervedml@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 1, 2016 | Sep 30, 2020 | Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2019 | Sep 30, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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In our clinical study, the person who performed radiographic evaluations before and after treatment did not know about the treatments received by the participants.
| home exercise program for scoliosis | Other |
|
In the second group there is only home exercise program for scoliosis. home exercise program for scoliosis |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gross Motor Function Classification System (GMFCS) | The Gross Motor Function Classification System (GMFCS) is a 5 level classification system that describes the gross motor function of cerebral palsy on the basis of self-initiated movement abilities. GMCFS level I: Can walk indoors and outdoors and climb stairs without using hands for support. GMFCS level II:Can climb stairs with a railing GMFCS level III: Walks with assistive mobility devices indoors and outdoors on level surfaces GMFCS level IV: Walking ability severely limited even with assistive devices GMFCS level V: Has physical impairments that restrict voluntary control of movement | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
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| Primary | Pelvic Obliquity | pelvic obliquity is posture of pelvis in relation to the ground | Posted | Mean | Standard Deviation | degrees | 12 weeks |
|
|
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| Primary | Sagittal Balance | sagittal balance of the spine is the posture of the spine on the sagittal plane | Posted | Mean | Standard Deviation | degrees | 12 weeks |
|
|
|
| Secondary | Reimer's Migration Index (RMI) | it shows the degree of hip subluxation or dislocation | Posted | Mean | Standard Deviation | percentage of hip subluxation | 12 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Home Exercises for Scoliosis | In the second group there is only home exercise program for scoliosis. home exercise program for scoliosis | 0 | 14 | 0 | 14 | 0 | 14 |
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| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| pelvic tilt |
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| sacral slope |
|
| pelvic incidence |
|
| Sagittal vertical axis (SVA) |
|