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

NCT ID: NCT06234215

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2023-11-25

Brief Summary

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The aims of the study are to:

1. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
2. 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

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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.

Conditions

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Cerebral Palsy Spastic Diplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control group had functional task training

this group doing functional task training exercise for 50 min 3 times per week for two months

Group Type ACTIVE_COMPARATOR

functional task training

Intervention Type OTHER

functional exercise

study group had functional task training combined with electrical stimulation

this group doing functional task training exercise combined with electrical stimulation for 50 min 3 times per week for two months

Group Type EXPERIMENTAL

functional electrical stimulation

Intervention Type DEVICE

electrical stimulation during function

functional task training

Intervention Type OTHER

functional exercise

Interventions

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functional electrical stimulation

electrical stimulation during function

Intervention Type DEVICE

functional task training

functional exercise

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Randa Adel

specialist physiotherapy Randa Adel Mousa Mostafa Mousa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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‪Randa Adel‬, master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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‪Randa Adel‬

Ītāy al Bārūd, El-beheira, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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E.S and balance in diplegia

Identifier Type: -

Identifier Source: org_study_id