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Effects of Using Dynamic Elastomeric Fabric Orthoses

Primary Purpose

Cerebral Palsy, Movement Disorders, Neurologic Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
dynamic elastomeric fabric orthoses
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, dynamic orthoses, gait analysis, movement, neoprene, rehabilitation

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kırıkkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment

Control

Arm Description

Used dynamic elastomeric fabric orthoses with physiotherapy and rehabilitation program

Only physiotherapy and rehabilitation program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Step length
its percentage within two-step length
Single support phase
its percentage within two-step length

Full Information

First Posted
February 11, 2020
Last Updated
February 13, 2020
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04272398
Brief Title
Effects of Using Dynamic Elastomeric Fabric Orthoses
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Movement Disorders, Neurologic Disorder
Keywords
cerebral palsy, dynamic orthoses, gait analysis, movement, neoprene, rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Used dynamic elastomeric fabric orthoses with physiotherapy and rehabilitation program
Arm Title
Control
Arm Type
Experimental
Arm Description
Only physiotherapy and rehabilitation program
Intervention Type
Other
Intervention Name(s)
dynamic elastomeric fabric orthoses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
Second with Time and go test
Time Frame
8 weeks
Title
Walking speed
Description
(meter/second)
Time Frame
8 weeks
Title
Stance phase
Description
its percentage within gait cycle
Time Frame
8 weeks
Title
Swing phase
Description
its percentage within gait cycle
Time Frame
8 weeks
Title
Symmetry Index of Pelvic Movements
Description
percentage
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Step length
Description
its percentage within two-step length
Time Frame
8 weeks
Title
Single support phase
Description
its percentage within two-step length
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Bezgin, PhD
Organizational Affiliation
Kırıkkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale University
City
Kırıkkale
State/Province
Merkez
ZIP/Postal Code
81000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Using Dynamic Elastomeric Fabric Orthoses

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