Status:
COMPLETED
Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy
Lead Sponsor:
Umm Al-Qura University
Conditions:
Cerebral Palsy
Eligibility:
All Genders
8-10 years
Phase:
NA
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 c...
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 correc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04271618
Start Date
February 12 2020
End Date
April 1 2021
Last Update
April 28 2021
Active Locations (1)
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1
Maternity and Children Hospital
Mecca, Mecca Region, Saudi Arabia, 149239