Effect of Electrical Stimulation With Functional Task Tra... | NCT06234215

Studies
Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia

NCT06234215

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 31, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cerebral Palsy Spastic Diplegia

Interventions

functional electrical stimulation
functional task training

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

Jan 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

Jan 17, 2023Actual

Primary Completion Date

Sep 12, 2023Actual

Completion Date

Nov 25, 2023Actual

First Submitted Date

Jan 5, 2024

First Submission Date that Met QC Criteria

Jan 29, 2024

First Posted Date

Jan 31, 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

Jan 29, 2024

Last Update Posted Date

Jan 31, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Randa Adel, specialist physiotherapy Randa Adel Mousa Mostafa Mousa, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

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

The aims of the study are to:

Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.

Detailed Description

Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.

Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.

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
control group had functional task training	Active Comparator	this group doing functional task training exercise for 50 min 3 times per week for two months	Other: functional task training
study group had functional task training combined with electrical stimulation	Experimental	this group doing functional task training exercise combined with electrical stimulation for 50 min 3 times per week for two months	Device: functional electrical stimulation Other: functional task training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
functional electrical stimulation	Device	electrical stimulation during function	study group had functional task training combined with electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Humac balance system	static and dynamic balance when values inscrease the results are better.	two months

Secondary Outcomes

Measure	Description	Time Frame
Growth motor functional scale	measuring motor abilities standing and walking when values increase the results are better.	two months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Their ages will range from 7-11 years.
Both genders will be included.
Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
Their motor function will be at level I & II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
They will be understanding instructions.

Exclusion Criteria:

Children will be excluded from the study if they have any of the following criteria:

Musculoskeletal fixed deformities in upper limb, lower limb or spine.

Visual or hearing problems.
Epilepsy.
Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
‪Randa Adel‬, master	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
‪Randa Adel‬		Ītāy al Bārūd	El-beheira		Egypt

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

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Browse Branches

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