Clinical trial NCT03191552: The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Postural; Defect
Keywords: Cerebral palsy
lycra garments
orthosis
suit therapy
trunk control
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observational Model: Cohort Time Perspective: Prospective Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sitting Assessment Scale
timeFrame: Immediate after orthosis is worn
measure: Sitting Assessment Scale
timeFrame: 2 weeks
measure: Sitting Assessment Scale
timeFrame: 1 month
measure: Sitting Assessment Scale
timeFrame: 3 months
Secondary outcomes:
measure: Gross Motor Function Measure-B, Sitting Dimension
timeFrame: 2 weeks
measure: Gross Motor Function Measure-B, Sitting Dimension
timeFrame: 1 month
measure: Gross Motor Function Measure-B, Sitting Dimension
timeFrame: 3 months
measure: Box and Block Test (BBT)
timeFrame: Immediate after orthosis is worn
measure: Box and Block Test (BBT)
timeFrame: 2 weeks
measure: Box and Block Test (BBT)
timeFrame: 1 month
measure: Box and Block Test (BBT)
timeFrame: 3 months
measure: Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
timeFrame: 2 weeks
measure: Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
timeFrame: 1 month
measure: Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)
timeFrame: 3 months
measure: Parent Satisfaction Questionnaire Total Score
timeFrame: 2 weeks
measure: Parent Satisfaction Questionnaire Total Score
timeFrame: 1 month
measure: Parent Satisfaction Questionnaire Total Score
timeFrame: 3 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
name: Esra Giray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
name: Naime Evrim Karadag-Saygi, Prof
role: STUDY_CHAIR
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