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Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

NCT ID: NCT05063175

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-04-30

Brief Summary

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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

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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.

Conditions

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Kyphosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conventional Physical Therapy Protocol

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Conventional Physical Therapy Protocol

Intervention Type 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.

TheraTog orthotic undergarment with its strapping system

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umm Al-Qura University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Mohamed Abd El Kafy

Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ehab M Abd El Kafy, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Applied Medical Sciences - Umm Al Qura University

Locations

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Umm Al Qura University

Mecca, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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19-MED-01-0005

Identifier Type: -

Identifier Source: org_study_id