Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271618
• Other study ID #: Umm Al-Qura U
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2020
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• TheraTogs Orthotic Undergarment
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

Locations

Country	Name	City	State
Saudi Arabia	Maternity and Children Hospital	Mecca	Makkah

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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