Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

NCT04271618 | Completed DMC

• 1 other identifier: Umm Al-Qura U
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Traditional Treatment Arm

ACTIVE COMPARATOR

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

Other: TheraTogs Orthotic Undergarment

TheraTogs Undergarment Arm

EXPERIMENTAL

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

Interventions

TheraTogs Orthotic Undergarment OTHER

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

TheraTogs Undergarment Arm; Traditional Treatment Arm

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Maternity and Children Hospital

Mecca, Mecca Region, 149239, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shamekh M El-Shamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: February 12, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)