Cerebral Palsy
Conditions
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.
Interventions
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
Sponsors
Umm Al-Qura University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Thoracic kyphotic angle at 3 months | Baseline and 3 months post-intervention | Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system. |
| Change from baseline lumber lordotic angle at 3 months | Baseline and 3 months post-intervention | Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system. |
Countries
Saudi Arabia
Outcome results
None listed