Clinical trial NCT04769102: Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children
Official title: Effect of Different Seat Cushions Adaptation on Upper Extremity Function in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: seat cushions, upper extremity , cerebral palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: within 30 to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Out Patient Clinic of Faculty of Physical Therapy Cairo Uni
state: Giza- Beenelsarayat
Study officials:
affiliation: proffesor of peadiatric physical therapy Cairo Uni
name: Faten H. Abd El Azeem, Phd
role: STUDY_DIRECTOR
References: