Clincosm LogoSign in Get a demo

Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

Sponsor
Umm Al-Qura University (Other)
Overall Status
Completed
CT.gov ID
NCT04271618
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
13.6
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: TheraTogs Orthotic Undergarment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy: Randomized Controlled Trial
Actual Study Start Date :
Feb 12, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline Thoracic kyphotic angle at 3 months [Baseline and 3 months post-intervention]

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

  2. Change from baseline lumber lordotic angle at 3 months [Baseline and 3 months post-intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maternity and Children Hospital Mecca Makkah Saudi Arabia 149239

Sponsors and Collaborators

  • Umm Al-Qura University

Investigators

  • Principal Investigator: Shamekh M El-Shamy, Ph.D., Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shamekh Mohamed El-Shamy, Professor, Umm Al-Qura University
ClinicalTrials.gov Identifier:
NCT04271618
Other Study ID Numbers:
  • Umm Al-Qura U
First Posted:
Feb 17, 2020
Last Update Posted:
Apr 28, 2021
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cerebral Palsy

Study Results

No Results Posted as of Apr 28, 2021