Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

NCT05063175 | Completed

• 1 other identifier: 19-MED-01-0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Kyphosis

Keywords

Kyphosis; Balance; Fall Risk

Outcome Measures

Primary Outcomes (4)

• 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.

  [Data was collected at baseline, and 12 weeks after intervention commencement.]

• 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.

  [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)

  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)

  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.]

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Experimental Group

EXPERIMENTAL

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; Other: TheraTog orthotic undergarment with its strapping system

Interventions

Conventional Physical Therapy Protocol OTHER

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.

Control Group; Experimental Group

TheraTog orthotic undergarment with its strapping system OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al Qura University

Mecca, 21955, Saudi Arabia

Location

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ehab M Abd El Kafy, Ph.D

  Faculty of Applied Medical Sciences - Umm Al Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: January 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa

Locations

SA (1)