Clinical trial NCT05063175: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis
Keywords: Kyphosis
Balance
Fall Risk
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the thoracic kyphosis angle (°)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
measure: Change in the thoracic flexion and extension range of motion (degree).
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
measure: Change in the Overall Stability Indices {percentage value (%)} for the Fall Risk Test (test that assessed the change in postural stability)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
measure: Change in the Pediatric Balance Scale score (scale that assess the change in balance performance)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Umm Al Qura University
Study officials:
affiliation: Faculty of Applied Medical Sciences - Umm Al Qura University
name: Ehab M Abd El Kafy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: