NCT04769102

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 21, 2021

Last Update Submit

February 23, 2021

Conditions

Keywords

seat cushions, upper extremity , cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Spastic Cerebral Palsy

EXPERIMENTAL

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

Interventions

flat versus contoured customized seat cushions

Spastic Cerebral Palsy

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Out Patient Clinic of Faculty of Physical Therapy Cairo Uni

Cairo, Giza- Beenelsarayat, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Faten H. Abd El Azeem, Phd

    proffesor of peadiatric physical therapy Cairo Uni

    STUDY DIRECTOR

Central Study Contacts

Mohga M. Khalil, Msc.

CONTACT

Asmaa A. El barrawy, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of physical therapy, Biomechanic department, Faculty of Physical Therapy , Cairo Uni

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

February 1, 2021

Primary Completion

July 30, 2021

Study Completion

August 30, 2022

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations