Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

October 6, 2021 updated by: Ehab Mohamed Abd El Kafy, Umm Al-Qura University

The Influences of Kyphotic Posture Correction on Balance and Risk of Fall in Children With Cerebral Palsy.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Mecca, Saudi Arabia, 21955
        • Umm Al Qura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Control Group
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.
Other: Conventional Physical Therapy Protocol
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.
EXPERIMENTAL: Experimental Group
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.
Other: Conventional Physical Therapy Protocol
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.
Other: TheraTog orthotic undergarment with its strapping system
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the thoracic kyphosis angle (°)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
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.
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the thoracic flexion and extension range of motion (degree).
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
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.
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the Overall Stability Indices {percentage value (%)} for the Fall Risk Test (test that assessed the change in postural stability)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
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.
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the Pediatric Balance Scale score (scale that assess the change in balance performance)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
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.
[Data was collected at baseline, and 12 weeks after intervention commencement.]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Umm Al-Qura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-MED-01-0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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