Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

Effect of Different Seat Cushions Adaptation on Upper Extremity Function in Children With Spastic Cerebral Palsy

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: seat cushions

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza- Beenelsarayat
    • Cairo, Giza- Beenelsarayat, Egypt, 00202
      • Recruiting
      • Out Patient Clinic of Faculty of Physical Therapy Cairo Uni
      • Contact: Mohga M. Khalil, Msc.; Phone Number: 00201227643588; Email: dr_mohga_pt@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Faten H. Abd El Azeem, Phd, proffesor of peadiatric physical therapy Cairo Uni

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: seat cushions, upper extremity , cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: P.T.REC/012/003018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No