The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy
Condition: Cerebral Palsy; Postural; Defect
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): SPIO; conventional exercises
Intervention type(s): Device; Other
Intervention description(s): 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; range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Observational Model: Cohort Time Perspective: Prospective Randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; lycra garments; orthosis; suit therapy; trunk control