Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

Umm Al-Qura University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: TheraTogs Orthotic Undergarment

Study type: Interventional

Funder types: Other

Identifiers

NCT04271618

Umm Al-Qura U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Traditional Treatment Arm

Active Comparator group

Description:

Participants in this group will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months.

Treatment:

Other: TheraTogs Orthotic Undergarment

TheraTogs Undergarment Arm

Experimental group

Description:

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.

Treatment:

Other: TheraTogs Orthotic Undergarment