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The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03191552
Recruitment Status : Completed
First Posted : June 19, 2017
Results First Posted : December 14, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Marmara University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cerebral Palsy
Postural; Defect
Interventions Device: SPIO
Other: conventional exercises
Enrollment 26
Recruitment Details 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.
Pre-assignment Details

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
Arm/Group Title SPIO(Stabilizing Pressure Input Orthosis) 2 Hours SPIO (Stabilizing Pressure Input Orthosis) 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description

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 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 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

Period Title: Overall Study
Started 9 9 8
Completed 8 8 8
Not Completed 1 1 0
Reason Not Completed
Lost to Follow-up             1             0             0
Undergone surgery (Progressive hip dyspl             0             1             0
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises) Total
Hide Arm/Group Description

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 (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 group (received only conventional exercise therapy) 8 were recruited/ 8 completed the study Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
<=18 years 8 8 8 24
Between 18 and 65 years 0 0 0 0
>=65 years 0 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 8 participants 8 participants 8 participants 24 participants
64.29  (18.09) 60.5  (19.57) 55.63  (18.11) 61  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
2
  25.0%
1
  12.5%
2
  25.0%
5
  20.8%
Male
6
  75.0%
7
  87.5%
6
  75.0%
19
  79.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Cerebral palsy (CP) type  
Measure Type: Count of Participants
Unit of measure:  Participants
Diplegic Number Analyzed 8 participants 8 participants 8 participants 24 participants
1
  12.5%
0
   0.0%
1
  12.5%
2
   8.3%
Tetraplegic Number Analyzed 8 participants 8 participants 8 participants 24 participants
7
  87.5%
8
 100.0%
7
  87.5%
22
  91.7%
GMFCS Level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
GMFCS level 3 Number Analyzed 8 participants 8 participants 8 participants 24 participants
2
  25.0%
2
  25.0%
1
  12.5%
5
  20.8%
GMFCS level 4 Number Analyzed 8 participants 8 participants 8 participants 24 participants
6
  75.0%
6
  75.0%
7
  87.5%
19
  79.2%
[1]
Measure Description:

GMFCS© Robert Palisano, Peter Rosenbaum, Stephen Walter, Dianne Russell, Ellen Wood, Barbara Galuppi, 1997. CanChild Centre for Childhood Disability Research, McMaster University. (Reference: Dev Med Child Neurol 1997;39:214-223).

Levels I-V based on self-initiated movement, with emphasis on sitting, transfers, and mobility. Level I is highest functioning, level V is lowest

General:

I: walks without limitations II: walks with limitations III: walks using hand-held mobility device IV: self-mobility with limitations; may use powered mobility V: transported in manual wheelchair

1.Primary Outcome
Title Sitting Assessment Scale
Hide Description 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.
Time Frame Immediate after orthosis is worn
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Before Treatment Immediately After Orthosis Worn
Hide Arm/Group Description:
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)
Immediate evaluation after orthosis worn
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.56  (2.4) 15.06  (2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Sitting Assessment Scale
Hide Description 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
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.8  (3.15) 18  (1.7) 14.8  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.
Method Kruskal-Wallis
Comments [Not Specified]
3.Primary Outcome
Title Sitting Assessment Scale
Hide Description 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
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.5  (2.27) 18.63  (1.85) 15.13  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.
Method Kruskal-Wallis
Comments [Not Specified]
4.Primary Outcome
Title Sitting Assessment Scale
Hide Description 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
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.75  (1.75) 19.38  (1.19) 1.63  (2.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.
Statistical Test of Hypothesis P-Value 0.004
Comments Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title Gross Motor Function Measure-B, Sitting Dimension
Hide Description Evaluates 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).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
36.88  (14.16) 37  (11.26) 34  (7.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Secondary Outcome
Title Gross Motor Function Measure-B, Sitting Dimension
Hide Description Evaluates 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).
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
43.25  (12.24) 40.88  (11.68) 37.25  (9.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.570
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
7.Secondary Outcome
Title Gross Motor Function Measure-B, Sitting Dimension
Hide Description Evaluates 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).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
45  (9.04) 45.38  (7.52) 39.25  (10.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
8.Secondary Outcome
Title Box and Block Test (BBT)
Hide Description 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.
Time Frame Immediate after orthosis is worn
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Before Treatment İmmediate After Orthosis Wear
Hide Arm/Group Description:
Box and Block Test Score of 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)
Box and Block Test Score of SPIO groups immediate after the orthosis wear (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.18  (4.35) 15.06  (2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before Treatment, İmmediate After Orthosis Wear
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Box and Block Test (BBT)
Hide Description 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.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
14  (7.27) 12.63  (4.93) 14.75  (5.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title Box and Block Test (BBT)
Hide Description 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.
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.75  (6.76) 14  (5.4) 15.5  (6.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.889
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
11.Secondary Outcome
Title Box and Block Test (BBT)
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.63  (8.23) 14.88  (3.91) 15.75  (5.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
12.Secondary Outcome
Title Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
Hide Description

A 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).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.43  (0.97) 11.5  (0.76) 8.5  (2.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0,001
Comments Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.
Method Kruskal-Wallis
Comments [Not Specified]
13.Secondary Outcome
Title Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
Hide Description

A 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).
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.43  (0.79) 11  (0.93) 9  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
14.Secondary Outcome
Title Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
Hide Description

A 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).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Control group (received only conventional exercise therapy),
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.14  (1.07) 11  (0.93) 9.25  (2.05)
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Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours, Control (Conventional Exercises)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
15.Secondary Outcome
Title Parent Satisfaction Questionnaire Total Score
Hide Description

A 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).
Time Frame 2 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.14  (1.07) 30.13  (2.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Parent Satisfaction Questionnaire Total Score
Hide Description

A 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).
Time Frame 1 month
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.14  (1.21) 30.63  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Parent Satisfaction Questionnaire Total Score
Hide Description

A 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).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO 2 Hours SPIO 6 Hours
Hide Arm/Group Description:
SPIO 2 hours (worn SPIO 2 hours during therapy)
SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.29  (1.11) 30  (2.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPIO 2 Hours, SPIO 6 Hours
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Hide Arm/Group Description SPIO 2 hours (worn SPIO 2 hours during therapy) SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy) Control group (received only conventional exercise therapy),
All-Cause Mortality
SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SPIO 2 Hours SPIO 6 Hours Control (Conventional Exercises)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Outcome measures assesses body structure and function only. Effects of orthosis on activity and participation were not evaluated
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Esra Giray
Organization: Department of Physical medicine and Rehabilitation, Marmara University School of Medicine, Istanbul,Turkey
Phone: +90216624545 ext 6515
Publications of Results:
How does the TherSuit® works? TheraSuit® / TheraSuit Method®. http://www.suittherapy.com/therasuit%20info.htm.
Hylton N, Schoos KK. Deep Pressure Sensory Input. SPIO Flexible Compression Bracing. http://www.spioworks.com/files/Deep%20Pressure%20Sensory%20Input%20Hylton%20Schoos.pdf; 2007.
Knox V. The use of Lycra garments in children with cerebral palsy: A report of a descriptive clinical trial. The British Journal of Occupational Therapy 2003; 66: 71-7.
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03191552     History of Changes
Other Study ID Numbers: 09.2013.0351
First Submitted: June 8, 2017
First Posted: June 19, 2017
Results First Submitted: August 9, 2017
Results First Posted: December 14, 2017
Last Update Posted: January 19, 2018