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Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

TheraTogs Orthotic Undergarment

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts 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.

Sites / Locations

Maternity and Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Treatment Arm

TheraTogs Undergarment Arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from baseline Thoracic kyphotic angle at 3 months

Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system.

Change from baseline lumber lordotic angle at 3 months

Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system.

Secondary Outcome Measures

Full Information

NCT ID

NCT04271618

First Posted

February 12, 2020

Last Updated

April 26, 2021

Sponsor

Umm Al-Qura University

1. Study Identification

Unique Protocol Identification Number

NCT04271618

Brief Title

Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

February 12, 2020 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Traditional Treatment Arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

TheraTogs Undergarment Arm

Arm Type

Experimental

Arm 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.

Intervention Type

Other

Intervention Name(s)

TheraTogs Orthotic Undergarment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline Thoracic kyphotic angle at 3 months

Description

Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system.

Time Frame

Baseline and 3 months post-intervention

Title

Change from baseline lumber lordotic angle at 3 months

Description

Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system.

Time Frame

Baseline and 3 months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shamekh M El-Shamy, Ph.D.

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maternity and Children Hospital

City

Mecca

State/Province

Makkah

ZIP/Postal Code

149239

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

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