CompletedNot Applicable

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

Turkey (Türkiye)26 participantsStarted 2017-06-20

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

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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

What they're measuring

Sitting Assessment Scale

Timeframe: Immediate after orthosis is worn

Sitting Assessment Scale

Timeframe: 2 weeks

Sitting Assessment Scale

Timeframe: 1 month

Sitting Assessment Scale

Timeframe: 3 months

Trial details

NCT IDNCT03191552

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-20

Results submitted2017-08-09

View on ClinicalTrials.gov More Cerebral Palsy trials