Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection

This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Child, Only; Myofeedback
• Intervention / Treatment: Other: selected physical therapy program; Device: biofeedback; Device: neuromuscular electric stimulation

Detailed Description

Studies indicate that neuromuscular electrical stimulation is more effective than voluntary exercise in enhancing serum Brain-derived neurotrophic factor levels and improving muscle strength and mobility in children with conditions like cerebral palsy and spinal muscular atrophy. Myofeedback, particularly surface electromyography biofeedback, is beneficial for upper extremity function post-stroke, as it helps raise awareness and control of movements. Intensive electromyography biofeedback has shown significant recovery in hemiplegic children compared to traditional therapy. There is potential for a multimodal treatment approach that combines neuromuscular electrical stimulation and biofeedback to mitigate the effects of brain tumors on upper limb function and optimize Brain-derived neurotrophic factor levels.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Elmagd physical therapy centres, Teriaq oncology centre and Elite hospital.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 6-14 years post brain tumor surgery children.
• Children's hand use experience questionnaire between 25 and 50 on a scale of units.
• Grade 2 muscle power of wrist, elbow and finger extensors.
• Outpatient children.
• Post-operative brain tumour, which is located in one of the two hemispheres.
• After 6 weeks post-surgery.
• The child can follow orders and instructions.

Exclusion Criteria:

• Blindness.
• Deaf child.
• Skin diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: selected physical therapy program; The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks.	Other: selected physical therapy program; The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
Experimental: selected physical therapy program and biofeedback; Patient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program.	Other: selected physical therapy program; The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.; Device: biofeedback; During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
Experimental: selected physical therapy program and neuromuscular electric stimulation; The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.	Other: selected physical therapy program; The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.; Device: neuromuscular electric stimulation; The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of muscle activity	All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes. The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally. After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.	at baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of upper limb function	Using the short form of the Bruininks-Oseretsky Test, which includes fourteen selected test items, subtests 1, 2, 3, 4, and 7 are administered. The child is positioned sitting at a table. The time taken for each task is noted as part of the proficiency evaluation. Performance is recorded, and raw scores are converted to point scores using a conversion table. The better result from two trials for each item is taken, and the total points from the fourteen short items are recorded in the designated area.	at baseline and after 12 weeks
assessment of level of neurotrophic factor	Fasting blood samples were taken in potassium-methylene diamine tetra acetic acid tubes, centrifuged for 15 minutes at 3000 rpm, and the plasma was stored at -80°C before being sent to Myriad RBM for a 190-analyte multiplex immunoassay. Additionally, the Brain-derived neurotrophic factor enzyme-linked immunosorbent assay reliably measures whole blood Brain-derived neurotrophic factor with high reproducibility.	at baseline and after 12 weeks
assessment of dynamic spasticity of wrist and elbow flexors muscles	Dynamic spasticity of wrist and elbow flexors muscles will be analyzed at the study's start and end. Measurements will include resistance 1 (fast velocity movement through full range of motion to identify the point of catch), resistance 2 (passive range of motion), and the difference resistance 2-resistance 1 (dynamic spasticity component). The Modified Ashworth Scale serves as a clinical tool for assessing spasticity, employing quantitative measurements at two speeds: slow (resistance 2) and fast (resistance 1).	at baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemiplegia; Therapeutics; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Biofeedback, Psychology
• Other Study ID Numbers: Amr-phd

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No