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Effect of Surface EMG Biofeedback on Quadriceps Inhibition Release During Postoperative Knee Rehabilitation (BIOQUAD)

17 agosto 2026 aggiornato da: Hopitaux de Saint-Maurice

Effet du Biofeedback Par EMG de Surface Sur la levée d'Inhibition du Quadriceps en rééducation Post-opératoire du Genou

Arthrogenic muscle inhibition (AMI) is a common neurological impairment following knee surgery that limits voluntary quadriceps activation and delays functional recovery. Persistent AMI may contribute to muscle weakness, altered gait, and poorer rehabilitation outcomes. Although several rehabilitation strategies have been proposed, no complementary intervention has consistently demonstrated strong evidence for improving AMI.

This prospective single-case experimental study aims to evaluate whether visual biofeedback based on surface electromyography (sEMG) improves quadriceps motor performance during standard rehabilitation. Each participant will complete eight standardized rehabilitation sessions, including four sessions with visual sEMG biofeedback and four sessions without visual feedback. The order of the two conditions will be randomized, allowing each participant to serve as his or her own control.

The primary objective is to determine whether visual sEMG biofeedback improves the accuracy of quadriceps contraction, assessed by the percentage deviation from a predefined target. Secondary objectives include evaluation of motor engagement, motor control, muscle activation, perceived exertion, and pain.

Between three and five adult patients presenting AMI after knee surgery will be included. Because recovery patterns are highly individualized, a Single-Case Experimental Design (SCED) with repeated within-subject measurements has been selected to characterize individual treatment responses while minimizing inter-individual variability

Panoramica dello studio

Descrizione dettagliata

Arthrogenic muscle inhibition (AMI) is a reflexive neurological response commonly observed after knee surgery. It results from altered afferent input originating from the injured joint, leading to reduced voluntary activation of the quadriceps muscle. AMI contributes to muscle weakness, impaired knee extension, gait abnormalities, and delayed functional recovery. Persistent inhibition may negatively affect long-term rehabilitation outcomes.

Surface electromyography (sEMG) biofeedback provides real-time visual information about muscle activation, enabling patients to voluntarily adjust their contractions during rehabilitation exercises. Previous studies suggest that EMG biofeedback may improve neuromuscular activation and motor learning, although evidence remains limited.

The BIOQUAD study is a prospective, within-subject Single-Case Experimental Design (SCED) conducted in adult patients undergoing rehabilitation after knee surgery who present AMI. This design was selected because of the high inter-individual variability in neuromuscular recovery and the exploratory nature of the study. Each participant acts as his or her own control through repeated measurements under two experimental conditions.

Each participant will complete eight standardized rehabilitation sessions over approximately three weeks:

  • Four sessions with visual sEMG biofeedback.
  • Four sessions without visual feedback while EMG signals are still recorded.
  • The order of conditions will be randomized using a predefined balanced sequence to reduce learning and order effects.

At the beginning of each session, maximal quadriceps activation (EMGmax) will be calibrated using three maximal voluntary contractions. Participants will then perform six standardized contractions targeting 80% of EMGmax, each maintained for five seconds and separated by fifteen seconds of rest.

The primary endpoint is contraction accuracy, defined as the percentage deviation from the target muscle activation level. Secondary outcomes include:

time spent within the target activation zone (±5%);

  • motor latency;
  • maximal EMG activity (EMGmax);
  • motor engagement score;
  • perceived exertion (Borg scale);
  • pain intensity (Numeric Rating Scale). Data will be analyzed using SCED methodology with visual and descriptive analyses focusing on level, trend, variability, and overlap between experimental conditions. Results will primarily be interpreted at the individual participant level before descriptive synthesis across participants.

Tipo di studio

Interventistico

Iscrizione (Stimato)

5

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Saint-Maurice, Francia, 94410
        • Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • AMI following knee surgery, as classified by the Santi classification system
  • Aged 18 or older
  • Enrolled in or covered by a social security program
  • Able to understand instructions and participate in standardized rehabilitation sessions

Exclusion Criteria:

  • Acute pain.
  • Neurological condition.
  • Skin lesion at the electrode site.
  • Allergy to the electrode.
  • Under legal protective measures such as guardianship or court-ordered protection

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Visual sEMG Biofeedback
Participants perform standardized rehabilitation exercises with real-time visual surface electromyography biofeedback.
Participants perform standardized rehabilitation exercises while receiving real-time visual feedback of quadriceps muscle activity using surface electromyography (sEMG)
Comparatore attivo: No Visual Biofeedback
Participants perform the same standardized rehabilitation exercises without visual biofeedback. Surface EMG signals are recorded but not displayed to the participant.
Participants perform the same standardized rehabilitation exercises without visual biofeedback. Surface electromyography signals are recorded but are not displayed to the participant.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage Deviation From the Target Quadriceps Activation Level
Lasso di tempo: During each of the 8 rehabilitation sessions, over approximately 3 weeks
The percentage deviation between the quadriceps muscle activation achieved by the participant and the predefined target activation level of 80% of the maximal surface electromyography activity (EMGmax). The measure will be calculated for each contraction performed during sessions with visual sEMG biofeedback and sessions without visual biofeedback. The percentage deviation between the participant's quadriceps muscle activation and the predefined target activation level (80% of EMGmax). Lower values indicate greater contraction accuracy.
During each of the 8 rehabilitation sessions, over approximately 3 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time Spent Within the Target Quadriceps Activation Zone
Lasso di tempo: During each of the 8 rehabilitation sessions, over approximately 3 weeks
Duration, expressed in seconds, during which quadriceps muscle activation remains within ±5% of the predefined target level of 80% of EMGmax during each contraction. A longer time within the target zone indicates better motor control.
During each of the 8 rehabilitation sessions, over approximately 3 weeks
Quadriceps Motor Latency
Lasso di tempo: During each of the 8 rehabilitation sessions, over approximately 3 weeks
Time, expressed in seconds, between the instruction to initiate the contraction and the onset of the quadriceps muscle activation recorded by surface electromyography. A shorter latency indicates a faster motor response.
During each of the 8 rehabilitation sessions, over approximately 3 weeks
Maximal Quadriceps Surface Electromyography Activity
Lasso di tempo: At the beginning of each of the 8 rehabilitation sessions, over approximately 3 weeks
Maximum quadriceps muscle activation recorded by surface electromyography during the calibration procedure performed at the beginning of each session. EMGmax is determined from three maximal voluntary contractions lasting 5 seconds each
At the beginning of each of the 8 rehabilitation sessions, over approximately 3 weeks
Pain Intensity Assessed Using a Numeric Rating Scale
Lasso di tempo: At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
Participant-reported pain intensity assessed at the end of each rehabilitation session using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
Perceived Exertion Assessed Using the Borg Scale
Lasso di tempo: At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
Participant-reported perceived exertion assessed at the end of each rehabilitation session using the Borg CR10 Scale (range: 0-10). Higher scores indicate greater perceived exertion.
At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Sylvain SB BELOT, MD, Hôpitaux Paris Est Val-de-Marne (HPEVM)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

24 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

No plan to make individual participant data available to other researchers.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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