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Effects of Using Dynamic Elastomeric Fabric Orthoses

NCT04272398 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-17

No results posted yet for this study

Summary

Purpose: The aim of this study was to investigate the effects of dynamic elastomeric fabric orthoses (DEFOs) used for lower trunk and pelvis on balance, gait parameters, and pelvis symmetry in children with cerebral palsy.

Materials and Methods: Twenty-two children (7 girls, 15 boys) in an age range of 4-10 years, with spastic type cerebral palsy, and at gross motor function classification system levels 1 or 2 were included in the study. Children who met the inclusion criteria were randomly divided into two groups. Ten children were included in the control group (Group I) and 12 children were included in the orthosis group (Group II). Both groups received a physiotherapy and rehabilitation program twice a week for 8 weeks in accordance with neurodevelopmental treatment approaches. Children in Group II were treated with DEFOs in lower body and pelvis in addition to physiotherapy and rehabilitation sessions. The use frequency of the orthosis was extended over the course of the week during which they were active for 8 hours a day. After the demographic data of the children were recorded, the Pediatric Balance Scale and the Timed Up and Go Test were used for balance assessment. Gait parameters and kinematic values of the pelvis were evaluated using the BTS G-Walk®, a wireless mini digital gait analysis system.

Conditions

Interventions

OTHER

dynamic elastomeric fabric orthoses

Wore dynamic elastomeric fabric orthoses with a focus on the lower body and pelvis in addition to the physiotherapy and rehabilitation sessions. The frequency of the use of the orthosis was planned to extend through the week and they had the orthosis during their active hours during the day about 8 hours a day.

Sponsors & Collaborators

  • Kırıkkale University

    lead OTHER

Principal Investigators

  • Sabiha Bezgin, PhD · Kırıkkale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-02-01
Completion
2019-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272398 on ClinicalTrials.gov