Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy
NCT ID: NCT04271618
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-02-12
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Traditional Treatment Arm
Participants in this group will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
8 Years
10 Years
ALL
Yes
Sponsors
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Umm Al-Qura University
OTHER
Responsible Party
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Shamekh Mohamed El-Shamy
Professor
Principal Investigators
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Shamekh M El-Shamy, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Maternity and Children Hospital
Mecca, Mecca Region, Saudi Arabia
Countries
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Other Identifiers
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Umm Al-Qura U
Identifier Type: -
Identifier Source: org_study_id
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