Combined Auditory and Functional Electrical Stimulation o... | NCT07331480

Studies
Combined Auditory and Functional Electrical Stimulation on Gait in Hemiparesis

NCT07331480

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 12, 2026Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hemiparesis

Interventions

gait training
Exercise
control group gait 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

Dec 2025

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

Oct 10, 2025Actual

Primary Completion Date

Dec 10, 2025Actual

Completion Date

Dec 15, 2025Actual

First Submitted Date

Dec 8, 2025

First Submission Date that Met QC Criteria

Dec 28, 2025

First Posted Date

Jan 12, 2026Actual

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

Dec 28, 2025

Last Update Posted Date

Jan 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nahla Mohamed Ibrahim, assistant professor of pediatric physical therapy, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Hemiparetic cerebral palsy has been characterized increased the asymmetry in the distribution of body weight between the affected and unaffected lower limbs and ineffective foot clearance during swing phase. This has been shown to result in an increased in the abnormal gait. This study aims to investigate the effect of rhythmic auditory stimulation combined with functional electrical stimulation on gait in children with hemiparetic cerebral palsy.

Detailed Description

A few studies have examined the benefits of music therapy showed that that weight-bearing stance time on the paretic side and stride symmetry improved with rhythmic cueing. Furthermore, the variability of integrated amplitude ratios decreased during the midstance/push off phase on the paretic side.

Improving walking safety, speed, postural control, balance and gait training are essential objectives for gait rehabilitation for hemiparetic children to prevent falls and subsequently to improve quality of life.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator	regular physical therapy exercises	Other: gait training Other: Exercise Other: control group gait training
study group	Experimental	auditory and functional electrical stimulation effect on gait	Other: gait training Other: Exercise Other: control group gait training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gait training	Other	use combination of auditory stimulation and functional electrical stimulation effect on gait training in children with hemiparesis	control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gait parameters	step length in cm	3 months

Secondary Outcomes

Measure	Description	Time Frame
range of motion	hip range of motion	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: hemiparesiss children aged 6 to 10 -

Exclusion Criteria: recent Botox or lower limb surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 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, phd	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy		Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010291	Paresis

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided