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N/A 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

Bottom Line

View on ClinicalTrials.gov: NCT03191552 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Sitting Assessment Scale — 12.56; 15.06 units on a scale — p=0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SPIO (Device); conventional exercises (Other)
Age
Pediatric · 3+ yrs
Sex
All
Sponsor
Marmara University
Primary completion
Aug 2017

Outcome Measures

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

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.

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.

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