Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769102
• Other study ID #: P.T.REC/012/003018
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

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