Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: TheraTogs Orthotic Undergarment

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Mecca, Makkah, Saudi Arabia, 149239
      • Maternity and Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional Treatment Arm; Participants in this group will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months.	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
EXPERIMENTAL: TheraTogs Undergarment Arm; 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; 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

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

Collaborators and Investigators

• Sponsor: Umm Al-Qura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2020
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Umm Al-Qura U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No