NCT05316090

Brief Summary

Purpose of the study: To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 23, 2022

Last Update Submit

March 30, 2022

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Pediatric reach test

    Reaching score

    assessment after 6 weeks of intervention

Study Arms (2)

study group

EXPERIMENTAL

Children in study group treated using core stability exercises program in addition to traditional program

Procedure: Core stability exercises programProcedure: Traditional physical therapy program

control group

ACTIVE COMPARATOR

Children in the control group treated using traditional physical therapy program.

Procedure: Traditional physical therapy program

Interventions

Core stability exercises programPROCEDURE

Strengthening to the trunk muscles

study group
Traditional physical therapy programPROCEDURE

Neurodevelopmental training excercises

control groupstudy group

Eligibility Criteria

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

You may qualify if:

  • The age of the selected children ranged from 3 To 6 years old.
  • Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987).
  • Children with hemiparetic cerebral palsy

You may not qualify if:

  • \. Fructures and fixed 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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pediatric physical therapy

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 7, 2022

Study Start

February 8, 2021

Primary Completion

August 1, 2021

Study Completion

August 8, 2021

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)