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

NCT ID: NCT03191552

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2017-09-20

Brief 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.

Detailed 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.

Conditions

Cerebral Palsy; Postural; Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPIO 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.

Group Type: EXPERIMENTAL

SPIO

Intervention Type: 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

conventional exercises

Intervention Type: OTHER

range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

SPIO 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.

Group Type: EXPERIMENTAL

SPIO

Intervention Type: 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

conventional exercises

Intervention Type: OTHER

range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

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

Group Type: ACTIVE_COMPARATOR

conventional exercises

Intervention Type: OTHER

range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

Interventions

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

Intervention Type: DEVICE

conventional exercises

range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esra Giray, MD

Role: PRINCIPAL_INVESTIGATOR

Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Naime Evrim Karadag-Saygi, Prof

Role: STUDY_CHAIR

Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Locations

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: RESULT

PMID: 7789663 (View on PubMed)

How does the TherSuit® works? TheraSuit® / TheraSuit Method®. http://www.suittherapy.com/therasuit%20info.htm.

Reference Type: 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.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 9689245 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 16990228 (View on PubMed)

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.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 1760002 (View on PubMed)

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.

Reference Type: RESULT

PMID: 7615145 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30293457 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

09.2013.0351

Identifier Type: -

Identifier Source: org_study_id