Clinical trial NCT04990193: The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy
Official title: The Effect of Soft Orthoses and Strapping on Balance and Gait Performance in Children With Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Balance
Gait
Strapping
Orthoses
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most of the available studies that are relevant to motor rehabilitation for children with dyskinetic type of cerebral palsy are few and are comprised of small numbers of children. Further researches are necessary to explore new conservative therapeutic protocols and techniques that should contribute to control disorganized movement, handle postural asymmetry, maintain postural stability, and improve gait performance. Therefore, the objective of this study was to examine the effectiveness of soft orthosis and strapping system on balance, and gait performance in children with dyskinetic cerebral palsy.

Detailed description: Dyskinetic type of cerebral palsy typically results from extrapyramidal and basal ganglia damage. The most common dyskinetic movement disorders are choreoathetosis and dystonia. Their clinical features include fluctuation of muscle tone, involuntary and in-coordinated movement, and posture instability. These features have significant negative impacts on the children's quality of life and performance of daily activities. Management strategy for children with dyskinesia requires both medical and rehabilitative treatment. Most of the available studies that are relevant to their motor rehabilitation are few and comprised of small numbers of children. The therapeutic modalities currently used for their rehabilitation require more evidence to certain their efficacy. Moreover, further researches are necessary to explore new conservative therapeutic protocols and techniques that should correct postural instability and improve the poor mobility of these children The objective of this study was to examine the effectiveness of an orthotic undergarment which is (TheraTog orthosis), and its strapping system on balance and gait performance in children with dyskinetic cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Children of a confirmed diagnosis of dyskinetic cerebral palsy of choreoathetosis type were selected to participate in this study.
* Children (of both sexes) were between 12 and 16 years old were included .
* Their height and weight were more than 100 cm and 20 Kg respectively to be eligible for the evaluation process on the Biodex stability system.
* Children were able to comprehend and follow orders.
* Their gross motor development levels, as measured by Gross Motor Function Classification System, were between levels I and II.
* Throughout the study period, participating children were not subjected to any other physical therapy programs except the assigned treatment protocol.

Exclusion Criteria:

* Children were excluded from this study if they had inflexible spinal deformities interfering with spinal and limbs functional mobility.
* Children were also excluded if their skin were sensitive or inflamed to any materials used.
* Children who had seizures, perceptual disorders, visual problems, and auditory deficits did not participate as well.

Primary outcomes:
measure: Change in the Overall Stability Indices {percentage value (%)} for Postural Stability 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 assessed the change in balance performance )
timeFrame: Data was collected at baseline, and 12 weeks after intervention commencement.
measure: Change in the gait parameter (step length) (This parameter indicated the change of gait performance).
timeFrame: Data was collected at baseline, and 12 weeks after intervention commencement.
measure: Change in the gait parameter (gait cycle time) (This parameter indicated the change of gait performance).
timeFrame: Data was collected at baseline, and 12 weeks after intervention commencement.
measure: Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
timeFrame: Data was collected at baseline, and 12 weeks after intervention commencement.
measure: Change in the gait parameter (velocity) (This parameter indicated the change of gait 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: