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Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

Primary Purpose

Cerebral Palsy

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

seat cushions

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring seat cushions, upper extremity , cerebral palsy

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Their age ranged from three to six years old .
Spasticity ranged from 1+ to 2 grade according to Modified Ashwarth Scale .
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:

Visual and/or auditory defects which interfere with upper extremity functions.
Fixed deformity of one or both upper limbs which limit passive ROM in shoulder and elbow.
Children with mixed type, dyskinetic or ataxic cerebral palsy are excluded.
surgical intervention in both upper limbs or botulinum toxin injection in the last 6 months before the time of assessment .
Any recent trauma of one or Both upper limbs.

Sites / Locations

Out Patient Clinic of Faculty of Physical Therapy Cairo UniRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spastic Cerebral Palsy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04769102

First Posted

February 21, 2021

Last Updated

February 23, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04769102

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

July 30, 2021 (Anticipated)

Study Completion Date

August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

seat cushions, upper extremity , cerebral palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spastic Cerebral Palsy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

seat cushions

Intervention Description

flat versus contoured customized seat cushions

Primary Outcome Measure Information:

Title

Description

angular kinematic changes ( by degrees) will be measured by kinovea 2D software

Time Frame

within 30 to 60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Their age ranged from three to six years old . Spasticity ranged from 1+ to 2 grade according to Modified Ashwarth Scale . 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: Visual and/or auditory defects which interfere with upper extremity functions. Fixed deformity of one or both upper limbs which limit passive ROM in shoulder and elbow. Children with mixed type, dyskinetic or ataxic cerebral palsy are excluded. surgical intervention in both upper limbs or botulinum toxin injection in the last 6 months before the time of assessment . Any recent trauma of one or Both upper limbs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohga M. Khalil, Msc.

Phone

00201227643588

dr_mohga_pt@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Asmaa A. El barrawy, Phd

Phone

00201007195901

elbarrawy2006@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faten H. Abd El Azeem, Phd

Organizational Affiliation

proffesor of peadiatric physical therapy Cairo Uni

Official's Role

Study Director

Facility Information:

Facility Name

Out Patient Clinic of Faculty of Physical Therapy Cairo Uni

City

Cairo

State/Province

Giza- Beenelsarayat

ZIP/Postal Code

00202

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohga M. Khalil, Msc.

Phone

00201227643588

dr_mohga_pt@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

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Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

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