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Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

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ClinicalTrials.gov Identifier: NCT04769102
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Hamada Ahmed, Cairo University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: seat cushions Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Different Seat Cushions Adaptation on Upper Extremity Function in Children With Spastic Cerebral Palsy
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spastic Cerebral Palsy
spastic Cerebral palsy children will be adapted in adaptive seat with flat and then Contoured cushions while kinematic changes of upper limb reaching movement are monitored through video capture with kinovea 2D software motion analysis system.
 Device: seat cushions
flat versus contoured customized seat cushions


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: within 30 to 60 minutes ]
    angular kinematic changes ( by degrees) will be measured by kinovea 2D software


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769102


Contacts
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Contact: Mohga M. Khalil, Msc. 00201227643588 dr_mohga_pt@yahoo.com
Contact: Asmaa A. El barrawy, Phd 00201007195901 elbarrawy2006@yahoo.com

Locations
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Egypt
Out Patient Clinic of Faculty of Physical Therapy Cairo Uni Recruiting
Cairo, Giza- Beenelsarayat, Egypt, 00202
Contact: Mohga M. Khalil, Msc.    00201227643588    dr_mohga_pt@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Faten H. Abd El Azeem, Phd proffesor of peadiatric physical therapy Cairo Uni
More Information
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Responsible Party: Hamada Ahmed, lecture of physical therapy, Biomechanic department, Faculty of Physical Therapy , Cairo Uni, Cairo University
ClinicalTrials.gov Identifier: NCT04769102    
Other Study ID Numbers: P.T.REC/012/003018
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamada Ahmed, Cairo University:
seat cushions, upper extremity , cerebral palsy
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases