Trial Outcomes & Findings for Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial (NCT NCT03862625)
NCT ID: NCT03862625
Last Updated: 2021-10-20
Results Overview
cobb angle shows the curvature of the spine in the coronal plane
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-10-20
Participant Flow
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
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
a Modular Adaptive Seating System
n=15 Participants
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
n=15 Participants
In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
12 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
18 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
|
Gross Motor Function Classification System (GMFCS)
GMFCS level IV
|
4 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
6 Participants
n=30 Participants
|
|
Gross Motor Function Classification System (GMFCS)
GMFCS level V
|
11 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
24 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 12 weekscobb angle shows the curvature of the spine in the coronal plane
Outcome measures
| Measure |
a Modular Adaptive Seating System
n=15 Participants
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
n=14 Participants
In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis
|
|---|---|---|
|
Cobb Angle
|
23.77 degrees
Standard Deviation 12.98
|
26.31 degrees
Standard Deviation 9.99
|
PRIMARY outcome
Timeframe: 12 weekspelvic obliquity is posture of pelvis in relation to the ground
Outcome measures
| Measure |
a Modular Adaptive Seating System
n=15 Participants
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
n=14 Participants
In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis
|
|---|---|---|
|
Pelvic Obliquity
|
6.46 degrees
Standard Deviation 3.15
|
7.39 degrees
Standard Deviation 4.28
|
PRIMARY outcome
Timeframe: 12 weekssagittal balance of the spine is the posture of the spine on the sagittal plane
Outcome measures
| Measure |
a Modular Adaptive Seating System
n=15 Participants
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
n=14 Participants
In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis
|
|---|---|---|
|
Sagittal Balance
thoracal kyphosis
|
33.75 degrees
Standard Deviation 11.95
|
41.07 degrees
Standard Deviation 9.97
|
|
Sagittal Balance
lombar lordosis
|
36.25 degrees
Standard Deviation 9.90
|
36.16 degrees
Standard Deviation 9.43
|
|
Sagittal Balance
pelvic tilt
|
20.99 degrees
Standard Deviation 13.62
|
13.37 degrees
Standard Deviation 7.86
|
|
Sagittal Balance
sacral slope
|
31.04 degrees
Standard Deviation 14.93
|
31.84 degrees
Standard Deviation 11.4
|
|
Sagittal Balance
pelvic incidence
|
52.4 degrees
Standard Deviation 11.9
|
45.22 degrees
Standard Deviation 11.34
|
|
Sagittal Balance
Sagittal vertical axis (SVA)
|
10.93 degrees
Standard Deviation 7.46
|
13.48 degrees
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: 12 weeksit shows the degree of hip subluxation or dislocation
Outcome measures
| Measure |
a Modular Adaptive Seating System
n=15 Participants
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
n=14 Participants
In the second group there is only home exercise program for scoliosis.
home exercise program for scoliosis
|
|---|---|---|
|
Reimer's Migration Index (RMI)
RMI for right hip
|
26.27 percentage of hip subluxation
Standard Deviation 11.20
|
22.85 percentage of hip subluxation
Standard Deviation 7.65
|
|
Reimer's Migration Index (RMI)
RMI for left hip
|
39.80 percentage of hip subluxation
Standard Deviation 22.28
|
32.43 percentage of hip subluxation
Standard Deviation 9.70
|
Adverse Events
a Modular Adaptive Seating System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Exercises for Scoliosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place