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To evaluate the effects and feasibility of lycra based compression garment called Stabilizing Pressure Input Orthosis (SPIO) vest on posture and balance during sitting and gross manuel dexterity, parent satisfaction with the garment and to to compare 2 hours vs 6 hours of daily wear time.
Cerebral palsy (CP) is a disorder of development of movement and posture due to non-progressive lesion in fetal or infant brain. Postural control in children with cerebral palsy (CP) is deteriorated due to inappropriate muscle force and lack of sensory integration. The trunk which is found in the centre of the body plays a crucial role in postural control. Research and treatments in CP have focused on extremities rather than trunk control. Both evaluation and treatment of trunk impairment have not been adequately addressed in previously published studies. Improved proximal stability obtained by a better trunk control may lead to improvements in upper extremity function.
Dynamic elastomeric fabric orthosis (DEFO) which are lycra based compression garments provide extra proprioceptive information which enhances body awareness. The more correct proprioceptive input result in the more proper alignment. Vest type dynamic elastomeric fabric orthosis (DEFO) is composed of a front part which is compromised of double-or triple-layer of lycra fabric attached to velcro sensitive neoprene back panel. Thus, it provides adjustable compression around the shoulder, trunk, pelvis, and hips. It is proposed that these orthotic garments provides stabilization of the trunk, shoulder and pelvis girdle and thus improve proximal stability and upper extremity function. Children with sensory deficits and poor muscle strength including children with neuromotor developmental disorders and hypotonia can benefit from the use of vest type dynamic elastomeric fabric orthosis. Severe restricted pulmonary function and refractory cyanosis are absolute contraindications for lycra based orthosis use while having severe reflux symptoms, uncontrolled epilepsy, cardiovascular circulatory disorders and being diagnosed with diabetes are relative contraindications. The adverse events pertaining to the use of these orthoses are difficulty in donning/doffing, toileting problems such as constipation and urinary leakage, decrease in respiratory function, heat and skin discomfort. Due to those unwanted effects, it can be assumed that longer wear time of the orthosis may lower compliance. However, the optimal wear time for vest type dynamic elastomeric fabric orthosis has not been established so far. The reported wear time of suit therapies range from 2 to12 hours a day during 2-12 weeks. The aim of this study was to investigate if the use of a vest type dynamic elastomeric fabric orthosis (DEFO) vest type dynamic elastomeric fabric orthosis is feasible or not and will lead to improvement in sitting balance, sitting as a gross motor function and gross manuel dexterity. The secondary purposes of the present study are to evaluate parent satisfaction with the orthosis and to compare 2 hours vs 6 hours of daily wear time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIO 2 hours | Experimental | 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 6 hours | Experimental | 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. |
|
| Control(conventional exercises) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIO | Device | SPIO (stabilizing input pressure orthosis) 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting Assessment Scale | 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. | Immediate after orthosis is worn |
| Sitting Assessment Scale | 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 | 2 weeks |
| Sitting Assessment Scale | 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 | 1 month |
| Sitting Assessment Scale | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Measure-B, Sitting Dimension | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esra Giray, MD | Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Naime Evrim Karadag-Saygi, Prof | Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University School of Medicine Department of Physical Medicine and Rehabilitation | Istanbul | 34899 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7789663 | Result | Blair E, Ballantyne J, Horsman S, Chauvel P. A study of a dynamic proximal stability splint in the management of children with cerebral palsy. Dev Med Child Neurol. 1995 Jun;37(6):544-54. doi: 10.1111/j.1469-8749.1995.tb12041.x. | |
| Result | How does the TherSuit® works? TheraSuit® / TheraSuit Method®. http://www.suittherapy.com/therasuit%20info.htm. | ||
| Result | 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. | ||
| 21552074 |
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Not meeting inclusion criteria (n=10)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPIO 2 Hours | 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 |
| BG001 | SPIO 6 Hours |
| 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 | Sitting Assessment Scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediate after orthosis is worn |
|
6 months
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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 | SPIO 2 Hours | SPIO 2 hours (worn SPIO 2 hours during therapy) | 0 |
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Outcome measures assesses body structure and function only. Effects of orthosis on activity and participation were not evaluated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esra Giray | Department of Physical medicine and Rehabilitation, Marmara University School of Medicine, Istanbul,Turkey | +90216624545 | 6515 | girayesra@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2017 | Oct 7, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2017 | Oct 7, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2017 | Oct 7, 2017 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Observational Model: Cohort Time Perspective: Prospective Randomized controlled trial
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|
| conventional exercises | Other | range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills |
|
| 2 weeks |
| Gross Motor Function Measure-B, Sitting Dimension | 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). | 1 month |
| Gross Motor Function Measure-B, Sitting Dimension | 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). | 3 months |
| Box and Block Test (BBT) | 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. | Immediate after orthosis is worn |
| Box and Block Test (BBT) | 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. | 2 weeks |
| Box and Block Test (BBT) | 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. | 1 month |
| Box and Block Test (BBT) | 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. | 3 months |
| Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) | 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
| 2 weeks |
| Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) | 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 month |
| Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) | 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
| 3 months |
| Parent Satisfaction Questionnaire Total Score | 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
| 2 weeks |
| Parent Satisfaction Questionnaire Total Score | 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 month |
| Parent Satisfaction Questionnaire Total Score | 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
| 3 months |
| Result |
| Christy JB, Steed L. Commentary on "The effect of suit wear during an intensive therapy program in children with cerebral palsy". Pediatr Phys Ther. 2011 Summer;23(2):143. doi: 10.1097/PEP.0b013e318219352d. No abstract available. |
| 9689245 | Result | Hylton N, Allen C. The development and use of SPIO Lycra compression bracing in children with neuromotor deficits. Pediatr Rehabil. 1997 Apr-Jun;1(2):109-16. doi: 10.3109/17518429709025853. |
| Result | 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. |
| 16990228 | Result | Matthews M, Crawford R. The use of dynamic Lycra orthosis in the treatment of scoliosis: a case study. Prosthet Orthot Int. 2006 Aug;30(2):174-81. doi: 10.1080/03093640600794668. |
| 25412796 | Result | Saavedra S. Trunk control in cerebral palsy: are we ready to address the elephant in the room? Dev Med Child Neurol. 2015 Apr;57(4):309-10. doi: 10.1111/dmcn.12614. Epub 2014 Nov 20. No abstract available. |
| 1760002 | Result | Myhr U, von Wendt L. Improvement of functional sitting position for children with cerebral palsy. Dev Med Child Neurol. 1991 Mar;33(3):246-56. doi: 10.1111/j.1469-8749.1991.tb05114.x. |
| 7615145 | Result | Myhr U, von Wendt L, Norrlin S, Radell U. Five-year follow-up of functional sitting position in children with cerebral palsy. Dev Med Child Neurol. 1995 Jul;37(7):587-96. doi: 10.1111/j.1469-8749.1995.tb12047.x. |
| 30293457 | Derived | Giray E, Karadag-Saygi E, Ozsoy T, Gungor S, Kayhan O. The effects of vest type dynamic elastomeric fabric orthosis on sitting balance and gross manual dexterity in children with cerebral palsy: a single-blinded randomised controlled study. Disabil Rehabil. 2020 Feb;42(3):410-418. doi: 10.1080/09638288.2018.1501098. Epub 2018 Oct 7. |
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.
| BG002 | Control (Conventional Exercises) | Control group (received only conventional exercise therapy) 8 were recruited/ 8 completed the study |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cerebral palsy (CP) type | Count of Participants | Participants |
|
| GMFCS Level | 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 | Count of Participants | Participants |
|
| OG001 | Immediately After Orthosis Worn | Immediate evaluation after orthosis worn |
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| Primary | Sitting Assessment Scale | 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 | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Sitting Assessment Scale | 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 | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Primary | Sitting Assessment Scale | 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 | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Gross Motor Function Measure-B, Sitting Dimension | 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). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Secondary | Gross Motor Function Measure-B, Sitting Dimension | 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). | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Gross Motor Function Measure-B, Sitting Dimension | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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| Secondary | Box and Block Test (BBT) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediate after orthosis is worn |
|
|
|
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| Secondary | Box and Block Test (BBT) | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Secondary | Box and Block Test (BBT) | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Box and Block Test (BBT) | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) | 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
| Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Secondary | Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) | 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
| Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) | 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
| Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Parent Satisfaction Questionnaire Total Score | 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
| Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Secondary | Parent Satisfaction Questionnaire Total Score | 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
| Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Parent Satisfaction Questionnaire Total Score | 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
| Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | SPIO 6 Hours | SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy) | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Control (Conventional Exercises) | Control group (received only conventional exercise therapy), | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
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| Title | Measurements |
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