N/A Completed N=26 Randomized Double-blind Treatment

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

Cerebral Palsy · Postural; Defect

Source: ClinicalTrials.gov NCT03191552 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcomePrimary: Sitting Assessment Scale — 12.56; 15.06 units on a scale — p=0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Sitting Assessment Scale	17.75; 19.38; 1.63	0.004 sig
SECONDARY Gross Motor Function Measure-B, Sitting Dimension	45; 45.38; 39.25	0.334
SECONDARY Box and Block Test (BBT)	15.63; 14.88; 15.75	0.956
SECONDARY Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)	11.14; 11; 9.25	0.08
SECONDARY Parent Satisfaction Questionnaire Total Score	31.29; 30	0.27

Eligibility Criteria

Inclusion Criteria

being classified at Gross Motor Function Classification System (GMFCS) level III-IV
being classified at Manual Ability Classification System (MACS) level III-IV
being able to understand and execute given instructions for evaluations
parental acceptance of using the lycra based compression garment.

Exclusion Criteria

serious respiratory restriction
having refractory cyanosis or circulatory disorder
having undergone lycra compression orthosis treatment programme previously
having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year
severe scoliosis (Cobb angle (CA) >40°)
uncontrolled epilepsy
having intrathecal baclofen pump
having undergone selective dorsal rhizotomy
having reflux more than 3 times a week.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03191552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.