Cerebral Palsy, Neuromuscular Scoliosis
Conditions
Keywords
cerebral palsy, scoliosis, adaptive seating system, sagittal balance, pelvic obliquity, coronal balance
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.
Interventions
DEVICEa modular adaptive seating system
OTHERhome exercise program for scoliosis
Sponsors
Merve Damla Korkmaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cobb Angle | 12 weeks | cobb angle shows the curvature of the spine in the coronal plane |
| Pelvic Obliquity | 12 weeks | pelvic obliquity is posture of pelvis in relation to the ground |
| Sagittal Balance | 12 weeks | sagittal balance of the spine is the posture of the spine on the sagittal plane |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reimer's Migration Index (RMI) | 12 weeks | it shows the degree of hip subluxation or dislocation |
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Home Exercises for Scoliosis In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | a Modular Adaptive Seating System | Home Exercises for Scoliosis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Gross Motor Function Classification System (GMFCS) GMFCS level IV | 4 Participants | 2 Participants | 6 Participants |
| Gross Motor Function Classification System (GMFCS) GMFCS level V | 11 Participants | 13 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
Cobb Angle
cobb angle shows the curvature of the spine in the coronal plane
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| a Modular Adaptive Seating System | Cobb Angle | 23.77 degrees | Standard Deviation 12.98 |
| Home Exercises for Scoliosis | Cobb Angle | 26.31 degrees | Standard Deviation 9.99 |
Primary
Pelvic Obliquity
pelvic obliquity is posture of pelvis in relation to the ground
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| a Modular Adaptive Seating System | Pelvic Obliquity | 6.46 degrees | Standard Deviation 3.15 |
| Home Exercises for Scoliosis | Pelvic Obliquity | 7.39 degrees | Standard Deviation 4.28 |
Primary
Sagittal Balance
sagittal balance of the spine is the posture of the spine on the sagittal plane
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| a Modular Adaptive Seating System | Sagittal Balance | thoracal kyphosis | 33.75 degrees | Standard Deviation 11.95 |
| a Modular Adaptive Seating System | Sagittal Balance | pelvic tilt | 20.99 degrees | Standard Deviation 13.62 |
| a Modular Adaptive Seating System | Sagittal Balance | pelvic incidence | 52.4 degrees | Standard Deviation 11.9 |
| a Modular Adaptive Seating System | Sagittal Balance | sacral slope | 31.04 degrees | Standard Deviation 14.93 |
| a Modular Adaptive Seating System | Sagittal Balance | Sagittal vertical axis (SVA) | 10.93 degrees | Standard Deviation 7.46 |
| a Modular Adaptive Seating System | Sagittal Balance | lombar lordosis | 36.25 degrees | Standard Deviation 9.9 |
| Home Exercises for Scoliosis | Sagittal Balance | Sagittal vertical axis (SVA) | 13.48 degrees | Standard Deviation 6.58 |
| Home Exercises for Scoliosis | Sagittal Balance | pelvic incidence | 45.22 degrees | Standard Deviation 11.34 |
| Home Exercises for Scoliosis | Sagittal Balance | thoracal kyphosis | 41.07 degrees | Standard Deviation 9.97 |
| Home Exercises for Scoliosis | Sagittal Balance | lombar lordosis | 36.16 degrees | Standard Deviation 9.43 |
| Home Exercises for Scoliosis | Sagittal Balance | pelvic tilt | 13.37 degrees | Standard Deviation 7.86 |
| Home Exercises for Scoliosis | Sagittal Balance | sacral slope | 31.84 degrees | Standard Deviation 11.4 |
Secondary
Reimer's Migration Index (RMI)
it shows the degree of hip subluxation or dislocation
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| a Modular Adaptive Seating System | Reimer's Migration Index (RMI) | RMI for right hip | 26.27 percentage of hip subluxation | Standard Deviation 11.2 |
| a Modular Adaptive Seating System | Reimer's Migration Index (RMI) | RMI for left hip | 39.80 percentage of hip subluxation | Standard Deviation 22.28 |
| Home Exercises for Scoliosis | Reimer's Migration Index (RMI) | RMI for left hip | 32.43 percentage of hip subluxation | Standard Deviation 9.7 |
| Home Exercises for Scoliosis | Reimer's Migration Index (RMI) | RMI for right hip | 22.85 percentage of hip subluxation | Standard Deviation 7.65 |