Effect of Biofeedback and Functional Electrical Stimulation in Children

Combined Effect of Biofeedback and Functional Electrical Stimulation on Upper Limb Functions in Children With Hemiplegia

40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years

Study Overview

• Status: Recruiting
• Conditions: Hemiplegia
• Intervention / Treatment: Procedure: Physical therapy program; Device: biofeedback

Detailed Description

40 children with hemiplegia cerebral palsy from both sex will be recruited ,their age ranged from 5-10 years, treatment includes functional electrical nerve stimulation and biofeedback to assess their combined effect on upper limb function

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa T Ramadan, M.SC; Phone Number: 01019320008; Email: dr.alaataha@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Recruiting
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Their age will range from 5 to 10 years.
• Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (MAS) (Bohannon and Smith, 2011).
• Their UL ability function will be at level II according to Manual Ability Classification System (MACS) (Penta et al., 2001).
• They will be able to follow instructions.

Exclusion Criteria:

• Loss of sensation
• The presence of visual or auditory impairments.
• Musculoskeletal problems or fixed deformities in the upper extremities.
• Seizures.
• Surgical interference in upper limbs.
• Botulinum toxin injections in the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; Physical therapy program The exercise session for one hour for each child , conducted 3times/ week for 3 successive months.; Flexibility exercises for shorted muscles and spastic muscles.; Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.; Postural control exercise in different positions and different surfaces; General endurance training; Exercises to facilitate hand function; Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand	Procedure: Physical therapy program; Flexibility exercises for shorted muscles and spastic muscles, Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles, Postural control exercise in different positions and different surfaces, General endurance training, Exercises to facilitate hand function, Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand
Experimental: Group B; The exercise session for one hour for each child same as group A, conducted 3times/ week for 3 successive months plus the combined biofeedback therapy and FES at anti spastic muscles (shoulders flexors, elbow and wrist extensors	Procedure: Physical therapy program; Flexibility exercises for shorted muscles and spastic muscles, Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles, Postural control exercise in different positions and different surfaces, General endurance training, Exercises to facilitate hand function, Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand; Device: biofeedback; biofeedback therapy and FES at anti spastic muscles(shoulders flexors, elbow and wrist extensors) while doing specific exercises (including basic reaching, grasping, carrying, release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hand function in children with CP	hand function in children with CP will be assessed by The Quality of Upper Extremity Skills Test	pre intervention and re assessed after 3 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion will be assessed using Electronic goniometer	pre intervention and re assessed after 3 months of treatment
muscle grip strength	muscle grip strength will be assessed using Hand held dynamometer	pre intervention and re assessed after 3 months of treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Khaled A Mamdouh, PHD, Professor of physical therapy; Study Director: Eman I Alhadedy, PHD, Professor of physical therapy; Study Director: Amira I Fathi, Lecturer of physical therapy

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Paralysis; Hemiplegia
• Other Study ID Numbers: 012/005003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No