Trial Outcomes & Findings for The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy (NCT NCT03191552)
NCT ID: NCT03191552
Last Updated: 2018-01-19
Results Overview
Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively.
COMPLETED
NA
26 participants
Immediate after orthosis is worn
2018-01-19
Participant Flow
Among the 36 children evaluated for recruitment, 26 of them met the inclusion criteria. There were two drop-outs throughout the follow-up period. Finally, data from 24 children were analyzed.
Not meeting inclusion criteria (n=10) * Mixed CP n=2 * Undergone surgery in past 6 months n=2 * BTX-A injection in past 3 months n=2 * Who do not understand and execute given instructions, severe CP n=4
Participant milestones
| Measure |
SPIO(Stabilizing Pressure Input Orthosis) 2 Hours
All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.
SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.
SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.
SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.
(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross
|
SPIO (Stabilizing Pressure Input Orthosis) 6 Hours
SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.
SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.
SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.
(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
|
Control (Conventional Exercises)
Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks
conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
SPIO(Stabilizing Pressure Input Orthosis) 2 Hours
All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.
SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.
SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.
SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.
(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross
|
SPIO (Stabilizing Pressure Input Orthosis) 6 Hours
SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.
SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.
SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.
(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
|
Control (Conventional Exercises)
Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks
conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Undergone surgery (Progressive hip dyspl
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SPIO 2 Hours
n=8 Participants
SPIO 2 hours (worn SPIO 2 hours during therapy)
9 were allocated, one of them lost follow up before the assessment at 1 month and 8 completed
|
SPIO 6 Hours
n=8 Participants
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy).
9 were allocated, one of them withdrew due to surgery for progressive hip dysplasia between the assessments at 1 month and 3 months and 8 completed.
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy) 8 were recruited/ 8 completed the study
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
64.29 months
STANDARD_DEVIATION 18.09 • n=8 Participants
|
60.5 months
STANDARD_DEVIATION 19.57 • n=8 Participants
|
55.63 months
STANDARD_DEVIATION 18.11 • n=8 Participants
|
61 months
STANDARD_DEVIATION 18 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Cerebral palsy (CP) type
Diplegic
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Cerebral palsy (CP) type
Tetraplegic
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
GMFCS Level
GMFCS level 3
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
GMFCS Level
GMFCS level 4
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Immediate after orthosis is wornPopulation: The immediate effect of orthosis could only be evaluated in SPIO groups because the orthosis is tailor made and only children in SPIO groups had the orthosis. Given that the number of the objects in each SPIO group is 8, immediate effect of the orthosis could only be evaluated in children recruited in SPIO groups.
Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively.
Outcome measures
| Measure |
Before Treatment
n=16 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=16 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Sitting Assessment Scale
|
12.56 units on a scale
Standard Deviation 2.4
|
15.06 units on a scale
Standard Deviation 2.54
|
—
|
PRIMARY outcome
Timeframe: 2 weeksSitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Sitting Assessment Scale
|
16.8 units on a scale
Standard Deviation 3.15
|
18 units on a scale
Standard Deviation 1.7
|
14.8 units on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 1 monthSitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Sitting Assessment Scale
|
17.5 units on a scale
Standard Deviation 2.27
|
18.63 units on a scale
Standard Deviation 1.85
|
15.13 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 3 monthsSitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Sitting Assessment Scale
|
17.75 units on a scale
Standard Deviation 1.75
|
19.38 units on a scale
Standard Deviation 1.19
|
1.63 units on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: 2 weeksEvaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Gross Motor Function Measure-B, Sitting Dimension
|
36.88 units on a scale
Standard Deviation 14.16
|
37 units on a scale
Standard Deviation 11.26
|
34 units on a scale
Standard Deviation 7.69
|
SECONDARY outcome
Timeframe: 1 monthEvaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Gross Motor Function Measure-B, Sitting Dimension
|
43.25 units on a scale
Standard Deviation 12.24
|
40.88 units on a scale
Standard Deviation 11.68
|
37.25 units on a scale
Standard Deviation 9.68
|
SECONDARY outcome
Timeframe: 3 monthsEvaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Gross Motor Function Measure-B, Sitting Dimension
|
45 units on a scale
Standard Deviation 9.04
|
45.38 units on a scale
Standard Deviation 7.52
|
39.25 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Immediate after orthosis is wornPopulation: The immediate effect of orthosis could only be evaluated in SPIO groups because the orthosis is tailor made and only children in SPIO groups had the orthosis. Given that the number of the objects in each SPIO group is 8, immediate effect of the orthosis could only be evaluated in children recruited in SPIO groups.
Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Outcome measures
| Measure |
Before Treatment
n=16 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=16 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Box and Block Test (BBT)
|
10.18 units on a scale
Standard Deviation 4.35
|
15.06 units on a scale
Standard Deviation 2.54
|
—
|
SECONDARY outcome
Timeframe: 2 weeksEvaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Box and Block Test (BBT)
|
14 units on a scale
Standard Deviation 7.27
|
12.63 units on a scale
Standard Deviation 4.93
|
14.75 units on a scale
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: 1 monthEvaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Box and Block Test (BBT)
|
14.75 units on a scale
Standard Deviation 6.76
|
14 units on a scale
Standard Deviation 5.4
|
15.5 units on a scale
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: 3 monthsEvaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Box and Block Test (BBT)
|
15.63 units on a scale
Standard Deviation 8.23
|
14.88 units on a scale
Standard Deviation 3.91
|
15.75 units on a scale
Standard Deviation 5.99
|
SECONDARY outcome
Timeframe: 2 weeksA non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below: Parent satisfaction survey 1. SPIO vest was easy to put on/off. 2. Child was comfartable during times the SPIO was worn. 3. Child's sitting balance improved. 4. Caring of the garment (cleaning vs) was easy. 5. Child's confidence was improved. 6. No problems about touletting occured. 7. I wish to attend this therapy programme again. 8. I consider attending this therapy programme in the future again. 9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
|
11.43 units on a scale
Standard Deviation 0.97
|
11.5 units on a scale
Standard Deviation 0.76
|
8.5 units on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: 1 monthA non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below: Parent satisfaction survey 1. SPIO vest was easy to put on/off. 2. Child was comfartable during times the SPIO was worn. 3. Child's sitting balance improved. 4. Caring of the garment (cleaning vs) was easy. 5. Child's confidence was improved. 6. No problems about touletting occured. 7. I wish to attend this therapy programme again. 8. I consider attending this therapy programme in the future again. 9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
|
11.43 units on a scale
Standard Deviation 0.79
|
11 units on a scale
Standard Deviation 0.93
|
9 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 3 monthsA non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below: Parent satisfaction survey 1. SPIO vest was easy to put on/off. 2. Child was comfartable during times the SPIO was worn. 3. Child's sitting balance improved. 4. Caring of the garment (cleaning vs) was easy. 5. Child's confidence was improved. 6. No problems about touletting occured. 7. I wish to attend this therapy programme again. 8. I consider attending this therapy programme in the future again. 9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
n=8 Participants
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
|
11.14 units on a scale
Standard Deviation 1.07
|
11 units on a scale
Standard Deviation 0.93
|
9.25 units on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: 2 weeksA non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below: Parent satisfaction survey 1. SPIO vest was easy to put on/off. 2. Child was comfartable during times the SPIO was worn. 3. Child's sitting balance improved. 4. Caring of the garment (cleaning vs) was easy. 5. Child's confidence was improved. 6. No problems about touletting occured. 7. I wish to attend this therapy programme again. 8. I consider attending this therapy programme in the future again. 9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Parent Satisfaction Questionnaire Total Score
|
31.14 units on a scale
Standard Deviation 1.07
|
30.13 units on a scale
Standard Deviation 2.59
|
—
|
SECONDARY outcome
Timeframe: 1 monthA non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below: Parent satisfaction survey 1. SPIO vest was easy to put on/off. 2. Child was comfartable during times the SPIO was worn. 3. Child's sitting balance improved. 4. Caring of the garment (cleaning vs) was easy. 5. Child's confidence was improved. 6. No problems about touletting occured. 7. I wish to attend this therapy programme again. 8. I consider attending this therapy programme in the future again. 9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Parent Satisfaction Questionnaire Total Score
|
31.14 units on a scale
Standard Deviation 1.21
|
30.63 units on a scale
Standard Deviation 1.3
|
—
|
SECONDARY outcome
Timeframe: 3 monthsA non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below: Parent satisfaction survey 1. SPIO vest was easy to put on/off. 2. Child was comfartable during times the SPIO was worn. 3. Child's sitting balance improved. 4. Caring of the garment (cleaning vs) was easy. 5. Child's confidence was improved. 6. No problems about touletting occured. 7. I wish to attend this therapy programme again. 8. I consider attending this therapy programme in the future again. 9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).
Outcome measures
| Measure |
Before Treatment
n=8 Participants
SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
|
Immediately After Orthosis Worn
n=8 Participants
Immediate evaluation after orthosis worn
|
Control (Conventional Exercises)
Control group (received only conventional exercise therapy),
|
|---|---|---|---|
|
Parent Satisfaction Questionnaire Total Score
|
31.29 units on a scale
Standard Deviation 1.11
|
30 units on a scale
Standard Deviation 2.33
|
—
|
Adverse Events
SPIO 2 Hours
SPIO 6 Hours
Control (Conventional Exercises)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Esra Giray
Department of Physical medicine and Rehabilitation, Marmara University School of Medicine, Istanbul,Turkey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place