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Visual and Auditory Electromyography Biofeedback Among Stroke Patients

14 juillet 2026 mis à jour par: Adnan Hashim, University of Lahore

Comparative Effects of Visual and Auditory Electromyography Biofeedback Combined With Conventional Physiotherapy on Balance, Functional Mobility, Motor Function, and Functional Independence Among Patients With Stroke: A Randomized Controlled Trial

Stroke commonly results in impairments of balance, mobility, and lower extremity motor function that limit independence in daily activities. Electromyography (EMG) biofeedback enhances motor relearning by providing real-time feedback regarding muscle activation. Although both visual and auditory EMG biofeedback have demonstrated benefits in stroke rehabilitation, evidence directly comparing these feedback modalities remains limited. This randomized controlled trial aims to compare the effects of visual and auditory EMG biofeedback, each combined with conventional physiotherapy, on balance, functional mobility, motor function, and functional independence in individuals with stroke.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

This randomized controlled trial will compare two modes of electromyography biofeedback in individuals with stroke undergoing lower extremity rehabilitation. Eighty-four eligible participants will be randomly allocated into two parallel groups using sealed-envelope randomization. Both groups will receive conventional physiotherapy consisting of lower extremity strengthening, balance, gait, and task-oriented exercises for 10 minutes per session. The experimental intervention will consist of either visual or auditory EMG biofeedback applied to the tibialis anterior muscle for 20 minutes. Treatment will be provided five sessions per week over three weeks (15 sessions). Outcomes including balance (Berg Balance Scale), functional mobility (Timed Up and Go Test), motor recovery (Fugl-Meyer Assessment-Lower Extremity), and functional independence (Barthel Index) will be assessed at baseline and immediately after completion of the intervention by a blinded assessor.

Type d'étude

Interventionnel

Inscription (Estimé)

84

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

  • Pakistan
      • Multan Khurd, Pakistan
        • Nishtar Hospital Multan

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age between 20 and 30 years
  • Male or female participants
  • Clinically diagnosed hemiplegic stroke.
  • Medically stable and able to participate in rehabilitation.
  • No visual impairment that would interfere with visual biofeedback.
  • No hearing impairment that would interfere with auditory biofeedback.
  • No sensory aphasia affecting the ability to understand study instructions.

Exclusion Criteria:

  • Traumatic injury or lesion affecting the lower extremities
  • Lower-limb amputation
  • Severe systemic disease that could interfere with participation
  • Peripheral vascular disease affecting the lower extremities
  • Fixed ankle contracture
  • Motion sickness or intolerance to rehabilitation technology

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
Expérimental: Visual EMG Biofeedback + Conventional Physiotherapy
Participants assigned to this arm will receive 10 minutes of conventional physiotherapy followed by 20 minutes of visual electromyography (EMG) biofeedback training. Surface EMG electrodes will be applied to the tibialis anterior muscle of the affected lower extremity. Real-time visual feedback displayed on a monitor will guide voluntary muscle activation to improve balance, motor recovery, functional mobility, and functional independence. Treatment will be provided for 30 minutes per session, five sessions per week for three weeks (15 sessions).
Dispositif: Visual Electromyography Biofeedback
Surface electromyography biofeedback will provide real-time visual feedback of muscle activity from the tibialis anterior muscle using graphical displays on a monitor. Participants will perform task-oriented lower extremity exercises while observing muscle activation to facilitate motor relearning and improve balance, functional mobility, and lower extremity motor function. The intervention will be delivered for 20 minutes per session, five sessions per week for three weeks.
Autre: Conventional Physiotherapy
Conventional physiotherapy will consist of lower extremity strengthening exercises, task-oriented functional training, balance exercises, gait training, stretching, and mobility exercises. All participants will receive 10 minutes of conventional physiotherapy before EMG biofeedback during each treatment session. The intervention will be delivered five sessions per week for three weeks.
Expérimental: Auditory EMG Biofeedback + Conventional Physiotherapy
Participants assigned to this arm will receive 10 minutes of conventional physiotherapy followed by 20 minutes of auditory electromyography (EMG) biofeedback training. Surface EMG electrodes will be applied to the tibialis anterior muscle of the affected lower extremity. Muscle activation will be translated into real-time auditory cues to facilitate voluntary muscle contraction, motor relearning, and improvement in balance and functional mobility. Treatment will be provided for 30 minutes per session, five sessions per week for three weeks (15 sessions).
Autre: Conventional Physiotherapy
Conventional physiotherapy will consist of lower extremity strengthening exercises, task-oriented functional training, balance exercises, gait training, stretching, and mobility exercises. All participants will receive 10 minutes of conventional physiotherapy before EMG biofeedback during each treatment session. The intervention will be delivered five sessions per week for three weeks.
Dispositif: Auditory Electromyography Biofeedback
Surface electromyography biofeedback will provide real-time auditory feedback corresponding to muscle activation of the tibialis anterior muscle. Participants will perform task-oriented lower extremity exercises while using auditory cues to facilitate muscle activation, movement coordination, and motor recovery. The intervention will be delivered for 20 minutes per session, five sessions per week for three weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Balance (Berg Balance Scale)
Délai: Baseline and Week 3 (Post-intervention)
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure of static and dynamic balance. Scores range from 0 to 56, with higher scores indicating better balance performance.
Baseline and Week 3 (Post-intervention)
Functional mobility (Timed Up and Go Test)
Délai: Baseline and Week 3 (Post-intervention)
Functional mobility will be assessed using the Timed Up and Go (TUG) Test. The time (seconds) required to stand from a chair, walk 3 meters, turn, return, and sit will be recorded. Lower completion times indicate better functional mobility.
Baseline and Week 3 (Post-intervention)
Motor function (Fugl-Meyer Assessment-Lower Extremity)
Délai: Baseline and Week 3 (Post-intervention)
Motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE). The FMA-LE contains 17 items with a total score ranging from 0 to 34. Higher scores indicate greater motor recovery.
Baseline and Week 3 (Post-intervention)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Functional independence (Barthel Index)
Délai: Baseline and Week 3 (Post-intervention)
Functional independence will be assessed using the Barthel Index (BI). The BI evaluates independence in activities of daily living, with scores ranging from 0 to 100. Higher scores indicate greater functional independence.
Baseline and Week 3 (Post-intervention)

Collaborateurs et enquêteurs

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

Parrainer

University of Lahore

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)

9 avril 2026

Achèvement primaire (Estimé)

10 septembre 2026

Achèvement de l'étude (Estimé)

12 octobre 2026

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité

14 juillet 2026

Première publication (Réel)

17 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UOL/IREB/26/19/01/0002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.

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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