Effect of Core Stability Excercises Program on Reaching i... | NCT05316090

Studies
Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy

NCT05316090

Sponsor

Cairo University

Status

Completed

Last Update Posted

Apr 7, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

Core stability exercises program
Traditional physical therapy program

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Aug 8, 2021Actual

First Submitted Date

Mar 23, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Apr 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Apr 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria:

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
Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program.
Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	Children in study group treated using core stability exercises program in addition to traditional program	Procedure: Core stability exercises program Procedure: 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

Name	Type	Description	Arm Group Labels	Other Names
Core stability exercises program	Procedure	Strengthening to the trunk muscles	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pediatric reach test	Reaching score	assessment after 6 weeks of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Fructures and fixed deformities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mai Abbass, Ph.D.	Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy, Cairo University		Cairo		11432	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided