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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Vest Type Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Children With Bilateral Cerebral Palsy: A Feasibility and Randomized, Single-blinded, Pilot Study

Conditions
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Cerebral Palsy, Postural; Defect

Intervention / Treatment
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* Device: SPIO
* Other: conventional exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being classified at Gross Motor Function Classification System (GMFCS) level III-IV being classified at Manual Ability Classification System (MACS) level III-IV being able to understand and execute given instructions for evaluations parental acceptance of using the lycra based compression garment. Exclusion Criteria: serious respiratory restriction having refractory cyanosis or circulatory disorder having undergone lycra compression orthosis treatment programme previously having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year severe scoliosis (Cobb angle (CA) >40°) uncontrolled epilepsy having intrathecal baclofen pump having undergone selective dorsal rhizotomy having reflux more than 3 times a week.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Observational Model: Cohort Time Perspective: Prospective Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPIO 2 hours<br>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. | Device: SPIO<br>* 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<br>Other: conventional exercises<br>* range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills<br>|
| Experimental: SPIO 6 hours<br>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. | Device: SPIO<br>* 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<br>Other: conventional exercises<br>* range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills<br>|
| Active Comparator: Control(conventional exercises)<br>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 | Other: conventional exercises<br>* range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 SPIO vest was easy to put on/off. Child was comfartable during times the SPIO was worn. Child's sitting balance improved. Caring of the garment (cleaning vs) was easy. Child's confidence was improved. No problems about touletting occured. I wish to attend this therapy programme again. I consider attending this therapy programme in the future again. 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). | 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 SPIO vest was easy to put on/off. Child was comfartable during times the SPIO was worn. Child's sitting balance improved. Caring of the garment (cleaning vs) was easy. Child's confidence was improved. No problems about touletting occured. I wish to attend this therapy programme again. I consider attending this therapy programme in the future again. 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). | 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 SPIO vest was easy to put on/off. Child was comfartable during times the SPIO was worn. Child's sitting balance improved. Caring of the garment (cleaning vs) was easy. Child's confidence was improved. No problems about touletting occured. I wish to attend this therapy programme again. I consider attending this therapy programme in the future again. 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). | 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 SPIO vest was easy to put on/off. Child was comfartable during times the SPIO was worn. Child's sitting balance improved. Caring of the garment (cleaning vs) was easy. Child's confidence was improved. No problems about touletting occured. I wish to attend this therapy programme again. I consider attending this therapy programme in the future again. 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). | 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 SPIO vest was easy to put on/off. Child was comfartable during times the SPIO was worn. Child's sitting balance improved. Caring of the garment (cleaning vs) was easy. Child's confidence was improved. No problems about touletting occured. I wish to attend this therapy programme again. I consider attending this therapy programme in the future again. 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). | 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 SPIO vest was easy to put on/off. Child was comfartable during times the SPIO was worn. Child's sitting balance improved. Caring of the garment (cleaning vs) was easy. Child's confidence was improved. No problems about touletting occured. I wish to attend this therapy programme again. I consider attending this therapy programme in the future again. 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). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral palsy, lycra garments, orthosis, suit therapy, trunk control