Clinical trial NCT04271618: Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy
Official title: Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to evaluate the the effect of Thera Togs soft orthotic undergarment on modulation of the spinal geometry and mobility in sagittal plan in children with spastic diplegic cerebral palsy.

Detailed description: Forty children with spastic diplegic CP will be assigned and randomly distributed into two equall groups (A\& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. Study group (B) will receive conventional rehabilitation protocol as in group (A) plus wearing TheraTogs soft orthotic undergarment. Children evaluation will be carried out before and after the intervention programs to assess postural deviations using the Formetric system.

Eligibility criteria: Inclusion Criteria:

* Have a definite diagnosis of spastic diplegia obtained from medical files or personal physicians and supported by magnetic resonance images (MRIs).
* Their weight should be less than 40 kg.
* The degree of spasticity in the affected lower extremity will ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
* The levels of gross motor function will be selected at level II according to Gross Motor Function Classification System.
* The children will be included have the ability to stand alone for five minutes.
* Children should be able to understand and follow instructions.
* The degree of the spinal kyphosis ,for all participated children , in sagittal plane should be not more than 55° as Kyphosis above 55° is considered as fixed hyper-kyphosis while

Exclusion Criteria:

* Children with GMFCS levels III, IV, and V or use any assistive mobility devices
* Children suffering from allergic problems in their skin.
* Children with visual, auditory or cognitive deficits.
* Fixed and significant deformities of the lower limb and spine.
* Children with surgical interference for the lower limb and spine within the previous 2 years.
* Children with seizures.
* Children with fixed hyper-kyphosis (kyphotic angle is more than 55°).
* Children who used any medications (e.g., steroids) that affect growth or body composition.

Primary outcomes:
measure: Change from baseline Thoracic kyphotic angle at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline lumber lordotic angle at 3 months
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Maternity and Children Hospital
state: Makkah
Study officials:
affiliation: Professor
name: Shamekh M El-Shamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: