NCT04644588

Brief Summary

Purpose: To determine the effect of scapular alignment on upper limb function in hemiparetic children and to find relation between scapular alignment of the affected, less affected limb and the upper limb function in children with spastic hemiparesis Subjects: Forty children with spastic hemiparetic cerebral palsy, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale. Methods: Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

November 20, 2020

Last Update Submit

February 25, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Children being assessed for scapular alignment.

    Children being assessed for scapular alignment using postural zone software.

    baseline ( enrolment)

  • Number of Children being assessed for upper limb function.

    Children being assessed for upper limb function using pediatric arm function test.

    baseline ( enrolment)

Study Arms (1)

Children being assessed for scapular alignment and upper limb function.

Children with hemiparetic cerebral palsy being assessed for scapular alignment and hand function using postural zone software to assess scapular alignment and pediatric arm function test toassess upper limb function .

Diagnostic Test: Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.

Interventions

Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.

Also known as: Children being assessed for scapular alignment and upper limb function.
Children being assessed for scapular alignment and upper limb function.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Forty children with spastic hemiplegic CP, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. They were able to follow instructions and understand commands.Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.

You may qualify if:

  • The age of the selected children was ranging from 3 to 6 years old .
  • Both genders were included.
  • They were able to follow instructions and understand commands.
  • Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.

You may not qualify if:

  • Upper limb surgery in the last 12 months.
  • Children which had contracture, fracture, and fixed deformities in the upper limb.
  • Children with muscleoskletal abnormalities as fixed back deformities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mai Abbass, Ph.D.

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Mai Elsayed Abbass, Lecturer of pediatric physical therapy

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 25, 2020

Study Start

February 1, 2020

Primary Completion

November 6, 2020

Study Completion

January 30, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations