Effects of Using Dynamic Elastomeric Fabric Orthoses

An Investigation of the Effects of Dynamic Elastomeric Fabric Orthoses Used for Lower Body and Pelvis in Children With Cerebral Palsy on Balance, Gait Parameters, and Pelvic Symmetry

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Movement Disorders; Neurologic Disorder
• Intervention / Treatment: Other: dynamic elastomeric fabric orthoses

Detailed Description

All groups received a physiotherapy and rehabilitation program two sessions per week, for 45 minutes, for a total of 8 weeks. The program was administered by a physiotherapist and prepared in accordance with neurodevelopmental treatment approaches. At other times, families continued to practice the exercises. An appropriate treatment plan was developed according to the needs and characteristics of each participant. Ensuring proper posture in different positions, increasing body awareness, and facilitating trunk extension were included in the treatment plan. For the development of postural control in standing and walking without support, weight transfer studies on the affected and less affected sides with trunk elongation were emphasized. Step up/down exercises were performed on both the affected and less affected sides. Supported by appropriate hand gripping, two-feet forward jumping, one-foot forward jumping, and weight transfer on one leg exercises were performed. Providing sensory inputs during all exercises was given importance. Exercises were conducted particularly to strengthen the antagonists of the spastic muscles. Stretching exercises were carried out in functional positions with active participation of the child as much as possible. The home program was shown to the family in detail in parallel with the physiotherapist's practices and the program was revised regularly. While Group I continued physiotherapy and rehabilitation sessions, the children in Group II wore DEFOs 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. In order to reduce the loosening of the fabric caused by extensive use, it was recommended that the orthosis be removed and reworn at two-hour intervals. The children wore the DEFOs for 8 weeks with this frequency. The frequency of use was monitored using a chart. Children were evaluated at the beginning of the study and after 8 weeks. An assessment environment was created for each child when they felt energetic and well. In order to prevent fatigue, short breaks were given. All evaluations were performed in the same environment in standardized conditions and without orthosis. Gait analysis was performed with bare feet.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Kırıkkale, Merkez, Turkey, 81000
      • Kırıkkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both the child and the family need to volunteer to participate in the study, diagnosis of spastic type CP with bilateral or unilateral involvement,
• being at level 1 or 2 based on the Gross Motor Function Classification System (GMFCS) and
• being in an age range of 4-10 years.

Exclusion Criteria:

• who had received botulinum toxin/surgery at the lower extremity and/or pelvis in the previous six months and those who were going to receive this treatment during the study were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment; Used dynamic elastomeric fabric orthoses with physiotherapy and rehabilitation program	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.
EXPERIMENTAL: Control; Only physiotherapy and rehabilitation program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Second with Time and go test	8 weeks
Walking speed	(meter/second)	8 weeks
Stance phase	its percentage within gait cycle	8 weeks
Swing phase	its percentage within gait cycle	8 weeks
Symmetry Index of Pelvic Movements	percentage	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length	its percentage within two-step length	8 weeks
Single support phase	its percentage within two-step length	8 weeks

Collaborators and Investigators

• Sponsor: Kırıkkale University
• Investigators: Principal Investigator: Sabiha Bezgin, PhD, Kırıkkale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; cerebral palsy; gait analysis; movement; dynamic orthoses; neoprene
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Disease; Nervous System Diseases; Movement Disorders
• Other Study ID Numbers: Kirikkale U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No