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Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

U

Umm Al-Qura University

Status

Completed

Conditions

Kyphosis

Treatments

Other: Conventional Physical Therapy Protocol
Other: TheraTog orthotic undergarment with its strapping system

Study type

Interventional

Funder types

Other

Identifiers

NCT05063175
19-MED-01-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

8 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Control Group
Active Comparator group
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.
Treatment:
Other: Conventional Physical Therapy Protocol
Experimental Group
Experimental group
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.
Treatment:
Other: Conventional Physical Therapy Protocol
Other: TheraTog orthotic undergarment with its strapping system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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