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Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

Primary Purpose

Kyphosis

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 Kyphosis focused on measuring Kyphosis, Balance, Fall Risk

Eligibility Criteria

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

The inclusion criteria were:

  • Children with a diagnosis of cerebral palsy of spastic diplegia.
  • They were all between 8 and 10 years old, of both sexes.
  • The degree of spasticity in the affected upper and lower extremity, was ranged between grades (1, 1+&2) according to Modified Ashworth Scale (MAS).
  • Children were cognitively able to understand and follow instructions.
  • The levels of their gross motor function were between level I and II according to the Gross - Motor Function Classification System (GMFCS).
  • They were able to stand alone for five to ten minutes without any assistance.
  • The degree of the spinal kyphosis in the sagittal plane did not exceed 45° (Cobb's angle).

The exclusion criteria were:

  • Children with any orthopedic condition or fixed deformity that interfere with the spinal and limbs functions.
  • Children who demonstrated allergic reactions to the adhesive tape or any other materials used in this study.
  • Children with surgical interference for the lower limb and spine within the previous 2 years.
  • Children with seizures, visual impairments, or perceptual problems.

Sites / Locations

  • Umm Al Qura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Children in the control group received the conventional physical therapy protocol which was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking.

The children in the experimental group received the conventional protocol applied to the control group. Further, they wore TheraTog orthotic undergarment with its strapping system for 8 hours daily for 12 successive weeks.

Outcomes

Primary Outcome Measures

Change in the thoracic kyphosis angle (°)
The following device (DIERS Formetric 3D/4D spine & posture analysis system) was used to examine the change in the thoracic kyphosis angle (°). This device supplies a thorough report about the alignment of the whole spine in one assessment session. It was used for assessing the sagittal plane of the back surface of the body according to a contactless 3D - scan.
Change in the thoracic flexion and extension range of motion (degree).
Spinal mouse, a computerized spinal evaluating device, was used for evaluating the range of motion of the spinal segment in a non-invasive way. The extension and flexion range of motion of the spine were measured by the spinal mouse. The measurements were recorded from the standing position of the children.
Change in the Overall Stability Indices {percentage value (%)} for the Fall Risk Test (test that assessed the change in postural stability)
The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level 12 was selected for applying the fall risk test. The result for every child was registered and compared to the normative data stored in the software of the device based on children age range.
Change in the Pediatric Balance Scale score (scale that assess the change in balance performance)
The Pediatric Balance Scale is a functional test that is used to evaluate balance impairments in children with motor deficits. The test consists of 14 tasks that assess balance performance in children. 0-4 is the rating score for each item, where zero is the minimum score and 56 is the maximum score for all tasks.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2021
Last Updated
October 6, 2021
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05063175
Brief Title
Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy
Official Title
The Influences of Kyphotic Posture Correction on Balance and Risk of Fall in Children With Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 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
Children with spastic diplegia are at an increased risk of spinal deformities. The most common types of these spinal deformities are scoliosis and kyphosis. Thoracic hyper-kyphosis may adversely affect balance in children with cerebral palsy . The treatment approaches for hyper-kyphosis involved both conservative and surgical treatments. The Conservative approach includes corrective exercises, positioning, and spinal braces. This study aimed to evaluate the effect of conservative orthotic management for kyphotic posture on balance control, and fall risk in cerebral palsied children of spastic diplegia.
Detailed Description
Kyphosis is a posterior convexity of the spine. Children with cerebral palsy show a higher probability of progression of the kyphotic curve. If it is not adequately treated, it becomes fixed where it requires surgical management. Children with cerebral palsy have more probability to balance impairment and falls than normal children and the consequences of that fall are great. The current studies do not properly examine the effectiveness of conservative orthoses on the therapeutic management of kyphosis in children with cerebral palsy. Also, there is a shortage of studies that evaluate how correction of the thoracic kyphosis influences the balance performance and fall risk in children with cerebral palsy. TheraTogs orthosis which consists of an orthotic undergarment and external strapping system has been designed to provide a soft and passive body compression to maintain a typical body postural alignment and to improve posture control. Therefore, the objective of this study was to investigate how the correction of dorsal hyper-kyphotic posture by the TheraTogs orthotic system could influence balance control, and fall risk in cerebral palsied children of spastic diplegia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis
Keywords
Kyphosis, Balance, Fall Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes 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 prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The children in the experimental group received the conventional protocol applied to the control group. Further, they wore TheraTog orthotic undergarment with its strapping system for 8 hours daily for 12 successive weeks.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy Protocol
Intervention Description
The conventional physical therapy protocol was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. The conventional therapeutic protocol for every child was three sessions per week for 12 successive weeks. Every treatment session was applied for two hours with a few minutes rest in between them.
Intervention Type
Other
Intervention Name(s)
TheraTog orthotic undergarment with its strapping system
Intervention Description
TheraTog orthotic undergarment with its strapping system was conducted for 8 hours daily for 12 successive weeks. It is made to be fitted directly on the skin as undergarments.
Primary Outcome Measure Information:
Title
Change in the thoracic kyphosis angle (°)
Description
The following device (DIERS Formetric 3D/4D spine & posture analysis system) was used to examine the change in the thoracic kyphosis angle (°). This device supplies a thorough report about the alignment of the whole spine in one assessment session. It was used for assessing the sagittal plane of the back surface of the body according to a contactless 3D - scan.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Title
Change in the thoracic flexion and extension range of motion (degree).
Description
Spinal mouse, a computerized spinal evaluating device, was used for evaluating the range of motion of the spinal segment in a non-invasive way. The extension and flexion range of motion of the spine were measured by the spinal mouse. The measurements were recorded from the standing position of the children.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Title
Change in the Overall Stability Indices {percentage value (%)} for the Fall Risk Test (test that assessed the change in postural stability)
Description
The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level 12 was selected for applying the fall risk test. The result for every child was registered and compared to the normative data stored in the software of the device based on children age range.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Title
Change in the Pediatric Balance Scale score (scale that assess the change in balance performance)
Description
The Pediatric Balance Scale is a functional test that is used to evaluate balance impairments in children with motor deficits. The test consists of 14 tasks that assess balance performance in children. 0-4 is the rating score for each item, where zero is the minimum score and 56 is the maximum score for all tasks.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria were: Children with a diagnosis of cerebral palsy of spastic diplegia. They were all between 8 and 10 years old, of both sexes. The degree of spasticity in the affected upper and lower extremity, was ranged between grades (1, 1+&2) according to Modified Ashworth Scale (MAS). Children were cognitively able to understand and follow instructions. The levels of their gross motor function were between level I and II according to the Gross - Motor Function Classification System (GMFCS). They were able to stand alone for five to ten minutes without any assistance. The degree of the spinal kyphosis in the sagittal plane did not exceed 45° (Cobb's angle). The exclusion criteria were: Children with any orthopedic condition or fixed deformity that interfere with the spinal and limbs functions. Children who demonstrated allergic reactions to the adhesive tape or any other materials used in this study. Children with surgical interference for the lower limb and spine within the previous 2 years. Children with seizures, visual impairments, or perceptual problems.
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
Yes
IPD Sharing Plan Description
- The data available is Case-by-case basis at the discretion of Primary Sponsor
IPD Sharing Time Frame
Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
IPD Sharing Access Criteria
Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa

Learn more about this trial

Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

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