Cerebral Palsy Clinical Trial
Official title:
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
Verified date | December 2017 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | September 20, 2017 |
Est. primary completion date | August 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility |
Inclusion Criteria: 1. being classified at Gross Motor Function Classification System (GMFCS) level III-IV 2. being classified at Manual Ability Classification System (MACS) level III-IV 3. being able to understand and execute given instructions for evaluations 4. parental acceptance of using the lycra based compression garment. Exclusion Criteria: 1. serious respiratory restriction 2. having refractory cyanosis or circulatory disorder 3. having undergone lycra compression orthosis treatment programme previously 4. having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year 5. severe scoliosis (Cobb angle (CA) >40°) 6. uncontrolled epilepsy 7. having intrathecal baclofen pump 8. having undergone selective dorsal rhizotomy 9. having reflux more than 3 times a week. |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University School of Medicine Department of Physical Medicine and Rehabilitation | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View Citation
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. — View Citation
How does the TherSuit® works? TheraSuit® / TheraSuit Method®. http://www.suittherapy.com/therasuit%20info.htm.
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. — View Citation
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.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Immediate after orthosis is worn | |
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 | 2 weeks | |
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 | 1 month | |
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 | 3 months | |
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). | 2 weeks | |
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). | 1 month | |
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). | 3 months | |
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. | Immediate after orthosis is worn | |
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. | 2 weeks | |
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. | 1 month | |
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. | 3 months | |
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 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 | |
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 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 | |
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 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 | |
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 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 | |
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 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 | |
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 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 |
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