Knee Joint Angle Affect Muscle Architecture in Children W... | NCT06481722

Studies
Knee Joint Angle Affect Muscle Architecture in Children With Cerebral Palsy

NCT06481722

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jul 1, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Spastic Cerebral Palsy

Interventions

cerebral palsy

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

Jun 2024

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

Apr 10, 2023Actual

Primary Completion Date

Nov 20, 2023Actual

Completion Date

Mar 20, 2024Actual

First Submitted Date

Jun 22, 2024

First Submission Date that Met QC Criteria

Jun 27, 2024

First Posted Date

Jul 1, 2024Actual

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

Jun 27, 2024

Last Update Posted Date

Jul 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mostafa S Ali, associate professor of pediatric physiotherapy, cairo university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy

Detailed Description

To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
cerebral palsy	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fascicle length	Fascicle length will be measured by ultrasonography	3 months
knee joint angle will be measured by digital Goniometer	knee joint angle will be measured by digital Goniometer	3 months
pennation angle	pennation angle will be measured by ultrasonography	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of spastic diplegia CP.
Age from 3 to 6 years.
Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
Level III motor function according to the Growth Motor Function Classification System.
Hamstring muscle tightness.
Able to understand and follow instructions.

Exclusion Criteria:

Epilepsy.
Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
Structural or fixed soft tissue deformities of the lower extremities.
Neurological or orthopedic surgery in the past 12 months.
Botox injection in the lower extremities in the past 6 months.

Accepts Healthy Volunteers

Not provided

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

To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy, 40 diplegic cerebral palsy children of both sexes will participate in this study.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Mostafa S Ali		Giza	Married	12668	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
D009128	Muscle Spasticity

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