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The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Conventional Physical Therapy Protocol
TheraTog orthotic undergarment with its strapping system
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Balance, Gait, Strapping, Orthoses

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children of a confirmed diagnosis of dyskinetic cerebral palsy of choreoathetosis type were selected to participate in this study.
  • Children (of both sexes) were between 12 and 16 years old were included .
  • Their height and weight were more than 100 cm and 20 Kg respectively to be eligible for the evaluation process on the Biodex stability system.
  • Children were able to comprehend and follow orders.
  • Their gross motor development levels, as measured by Gross Motor Function Classification System, were between levels I and II.
  • Throughout the study period, participating children were not subjected to any other physical therapy programs except the assigned treatment protocol.

Exclusion Criteria:

  • Children were excluded from this study if they had inflexible spinal deformities interfering with spinal and limbs functional mobility.
  • Children were also excluded if their skin were sensitive or inflamed to any materials used.
  • Children who had seizures, perceptual disorders, visual problems, and auditory deficits did not participate as well.

Sites / Locations

  • Umm Al Qura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Study group

Arm Description

Children in the control group received the conventional physical therapy protocol which was designed to improve axial stability and trunk steadiness during standing and walking.

The children in the study group received the conventional protocol given to the control group. Moreover, they wore TheraTog orthotic undergarment with its strapping system eight hours every day for twelve consecutive weeks.

Outcomes

Primary Outcome Measures

Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assessed the change in postural stability)
The Biodex Balance System was used to assess the Change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the children's ability to control their postural balance stability in all directions. High values % represent less stability and the children had difficulty in balance control. On the other hand lower values were indicative of a better balance control.
Change in the Pediatric Balance Scale score (scale that assessed the change in balance performance )
The Pediatric Balance Scale is a valid and reliable test to assess and re-assess balance deficits in children with mild and moderate motor disabilities. The test includes fourteen tasks that evaluate balance abilities and motor performance in children. 0-4 is the rating score for each item, where zero is the lowest score and 56 is the highest possible score for all tasks that indicate the best balance and motor performance ever.
Change in the gait parameter (step length) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: step length (cm).
Change in the gait parameter (gait cycle time) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: gait cycle time (seconds).
Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: cadence (steps/ minute).
Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: velocity (meter / second).

Secondary Outcome Measures

Full Information

First Posted
July 18, 2021
Last Updated
July 26, 2021
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT04990193
Brief Title
The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy
Official Title
The Effect of Soft Orthoses and Strapping on Balance and Gait Performance in Children With Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura 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
Most of the available studies that are relevant to motor rehabilitation for children with dyskinetic type of cerebral palsy are few and are comprised of small numbers of children. Further researches are necessary to explore new conservative therapeutic protocols and techniques that should contribute to control disorganized movement, handle postural asymmetry, maintain postural stability, and improve gait performance. Therefore, the objective of this study was to examine the effectiveness of soft orthosis and strapping system on balance, and gait performance in children with dyskinetic cerebral palsy.
Detailed Description
Dyskinetic type of cerebral palsy typically results from extrapyramidal and basal ganglia damage. The most common dyskinetic movement disorders are choreoathetosis and dystonia. Their clinical features include fluctuation of muscle tone, involuntary and in-coordinated movement, and posture instability. These features have significant negative impacts on the children's quality of life and performance of daily activities. Management strategy for children with dyskinesia requires both medical and rehabilitative treatment. Most of the available studies that are relevant to their motor rehabilitation are few and comprised of small numbers of children. The therapeutic modalities currently used for their rehabilitation require more evidence to certain their efficacy. Moreover, further researches are necessary to explore new conservative therapeutic protocols and techniques that should correct postural instability and improve the poor mobility of these children The objective of this study was to examine the effectiveness of an orthotic undergarment which is (TheraTog orthosis), and its strapping system on balance and gait performance in children with dyskinetic cerebral palsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Balance, Gait, Strapping, Orthoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Children in the control group received the conventional physical therapy protocol which was designed to improve axial stability and trunk steadiness during standing and walking.
Arm Title
Study group
Arm Type
Experimental
Arm Description
The children in the study group received the conventional protocol given to the control group. Moreover, they wore TheraTog orthotic undergarment with its strapping system eight hours every day for twelve consecutive weeks.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy Protocol
Intervention Description
The conventional physical therapy protocol was designed to improve axial stability and trunk steadiness during standing and walking. The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. Every treatment session was conducted for 2 hours with a 15-minutes rest between the two training hours.
Intervention Type
Other
Intervention Name(s)
TheraTog orthotic undergarment with its strapping system
Intervention Description
TheraTog orthotic undergarment with its strapping system was applied for eight hours every day for twelve consecutive weeks.
Primary Outcome Measure Information:
Title
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assessed the change in postural stability)
Description
The Biodex Balance System was used to assess the Change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the children's ability to control their postural balance stability in all directions. High values % represent less stability and the children had difficulty in balance control. On the other hand lower values were indicative of a better balance control.
Time Frame
Data was collected at baseline, and 12 weeks after intervention commencement.
Title
Change in the Pediatric Balance Scale score (scale that assessed the change in balance performance )
Description
The Pediatric Balance Scale is a valid and reliable test to assess and re-assess balance deficits in children with mild and moderate motor disabilities. The test includes fourteen tasks that evaluate balance abilities and motor performance in children. 0-4 is the rating score for each item, where zero is the lowest score and 56 is the highest possible score for all tasks that indicate the best balance and motor performance ever.
Time Frame
Data was collected at baseline, and 12 weeks after intervention commencement.
Title
Change in the gait parameter (step length) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: step length (cm).
Time Frame
Data was collected at baseline, and 12 weeks after intervention commencement.
Title
Change in the gait parameter (gait cycle time) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: gait cycle time (seconds).
Time Frame
Data was collected at baseline, and 12 weeks after intervention commencement.
Title
Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: cadence (steps/ minute).
Time Frame
Data was collected at baseline, and 12 weeks after intervention commencement.
Title
Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: velocity (meter / second).
Time Frame
Data was collected at baseline, and 12 weeks after intervention commencement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children of a confirmed diagnosis of dyskinetic cerebral palsy of choreoathetosis type were selected to participate in this study. Children (of both sexes) were between 12 and 16 years old were included . Their height and weight were more than 100 cm and 20 Kg respectively to be eligible for the evaluation process on the Biodex stability system. Children were able to comprehend and follow orders. Their gross motor development levels, as measured by Gross Motor Function Classification System, were between levels I and II. Throughout the study period, participating children were not subjected to any other physical therapy programs except the assigned treatment protocol. Exclusion Criteria: Children were excluded from this study if they had inflexible spinal deformities interfering with spinal and limbs functional mobility. Children were also excluded if their skin were sensitive or inflamed to any materials used. Children who had seizures, perceptual disorders, visual problems, and auditory deficits did not participate as well.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab M Abd El Kafy, Ph.D
Organizational Affiliation
Faculty of Applied Medical Sciences - Umm Al Qura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umm Al Qura University
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy

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