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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04769102
Other study ID # P.T.REC/012/003018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date August 30, 2022

Study information

Verified date February 2021
Source Cairo University
Contact Mohga M. Khalil, Msc.
Phone 00201227643588
Email dr_mohga_pt@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As the seating adaptations, ranging from simple to complex, standard and customized may facilitate optimal health and maximize functional participation despite limited postural control; the study will be conducted for determine the effect of contoured cushions as a seat adaptation on upper extremity function in children with spastic cerebral palsy and compare between the effect of flat cushion and contoured cushion in adaptive seating system on upper extremity function in children with spastic cerebral palsy.


Description:

As research continues to reveal the efficacy of ramped and contoured cushions on postural stability and alignment (Macdonald et al.,2015), it is likely that it will become accepted that such modifications will affect the UL functional level , mobility and rang of motion. Therefore, the purpose of this study was to examine the effect of contoured cushions as adaptive seating intervention on Upper extremity function in children with spastic cerebral palsy.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 30, 2022
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria: 1. Their age ranged from three to six years old . 2. Spasticity ranged from 1+ to 2 grade according to Modified Ashwarth Scale . 3. All children should be able to sit on the adaptive seat while head is upright independently and hands are free; preliminary test by Gross Motor Functional Measurement (GMFM) scale ranged score from ( 21 to 25 ) in sitting domain. Exclusion Criteria: Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. Visual and/or auditory defects which interfere with upper extremity functions. 2. Fixed deformity of one or both upper limbs which limit passive ROM in shoulder and elbow. 3. Children with mixed type, dyskinetic or ataxic cerebral palsy are excluded. 4. surgical intervention in both upper limbs or botulinum toxin injection in the last 6 months before the time of assessment . 5. Any recent trauma of one or Both upper limbs.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
seat cushions
flat versus contoured customized seat cushions

Locations

Country Name City State
Egypt Out Patient Clinic of Faculty of Physical Therapy Cairo Uni Cairo Giza- Beenelsarayat

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Angular kinematic changes in Upper extremity rang of motion in parallel to functional changes will be addressed while seat adaptations( flat and contoured cushions) will be applied for same participant. angular kinematic changes ( by degrees) will be measured by kinovea 2D software within 30 to 60 minutes
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