Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

NCT ID: NCT04769102

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-08-30

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

seat cushions

Intervention Type DEVICE

flat versus contoured customized seat cushions

Interventions

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seat cushions

flat versus contoured customized seat cushions

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hamada Ahmed

lecture of physical therapy, Biomechanic department, Faculty of Physical Therapy , Cairo Uni

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faten H. Abd El Azeem, Phd

Role: STUDY_DIRECTOR

proffesor of peadiatric physical therapy Cairo Uni

Locations

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Out Patient Clinic of Faculty of Physical Therapy Cairo Uni

Cairo, Giza- Beenelsarayat, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohga M. Khalil, Msc.

Role: CONTACT

00201227643588

Asmaa A. El barrawy, Phd

Role: CONTACT

00201007195901

Facility Contacts

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Mohga M. Khalil, Msc.

Role: primary

00201227643588

Other Identifiers

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P.T.REC/012/003018

Identifier Type: -

Identifier Source: org_study_id

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