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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03191552
Other study ID # 09.2013.0351
Secondary ID
Status Completed
Phase N/A
First received June 8, 2017
Last updated December 19, 2017
Start date June 20, 2017
Est. completion date September 20, 2017

Study information

Verified date December 2017
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SPIO
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
Other:
conventional exercises
range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

Locations

Country Name City State
Turkey Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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

Outcome

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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