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Completed

NCT Number: NCT04271618

Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

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.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity and Children Hospital

Mecca, Mecca Region, 149239, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change from baseline Thoracic kyphotic angle at 3 months

    Time frame: 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

    Time frame: Baseline and 3 months post-intervention

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

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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