Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

Study Overview
=================
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.

Official Title
-----------------
Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy: Randomized Controlled Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: TheraTogs Orthotic Undergarment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Treatment Arm<br>Participants in this group will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. | Other: TheraTogs Orthotic Undergarment<br>* Strapping undergarment made from a lightweight, breathable fabric that is velcro sensitive. It consists of sleeveless vest (tank-Top), two shorts (Hipster) each with two thigh cuffs and limb cuffs<br>|
| Experimental: TheraTogs Undergarment Arm<br>Participants in this group will receive the same conventional rehabilitation program as in traditional group in addition to wearing of TheraTogs soft orthotic undergarment with strapping system. | Other: TheraTogs Orthotic Undergarment<br>* Strapping undergarment made from a lightweight, breathable fabric that is velcro sensitive. It consists of sleeveless vest (tank-Top), two shorts (Hipster) each with two thigh cuffs and limb cuffs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Thoracic kyphotic angle at 3 months | Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system. | Baseline and 3 months post-intervention | 
| Change from baseline lumber lordotic angle at 3 months | Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system. | Baseline and 3 months post-intervention |