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

17 mai 2026 mis à jour par: Amr Mohamed Sabry Lotfi Amer, Cairo University
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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: selected physical therapy program
The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks.
Autre: 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.
Expérimental: 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.
Autre: 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.
Dispositif: 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.
Expérimental: 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.
Autre: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Assessment of muscle activity
Délai: at baseline and after 12 weeks
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Assessment of upper limb function
Délai: at baseline and after 12 weeks
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
Délai: at baseline and after 12 weeks
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
Délai: at baseline and after 12 weeks
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2024

Achèvement primaire (Réel)

1 juin 2025

Achèvement de l'étude (Réel)

1 septembre 2025

Dates d'inscription aux études

Première soumission

17 mai 2026

Première soumission répondant aux critères de contrôle qualité

17 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Amr-phd

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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