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

Без фазы С лечением Arthrogenic Muscle Inhibition Knee Injuries Postoperative Rehabilitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Visual Surface EMG Biofeedback, Standard Rehabilitation Without Visual Biofeedback.
Кому может быть актуально
Состояния в реестре: Arthrogenic Muscle Inhibition, Knee Injuries, Postoperative Rehabilitation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое Visual Surface EMG Biofeedback
    Participants perform standardized rehabilitation exercises while receiving real-time visual feedback of quadriceps muscle activity using surface electromyography (sEMG)
  • Поведенческое Standard Rehabilitation Without Visual Biofeedback
    Participants perform the same standardized rehabilitation exercises without visual biofeedback. Surface electromyography signals are recorded but are not displayed to the participant.

Первичные конечные точки

  • Percentage Deviation From the Target Quadriceps Activation Level [Срок оценки: During each of the 8 rehabilitation sessions, over approximately 3 weeks]
Вторичные конечные точки (5)
  • Time Spent Within the Target Quadriceps Activation Zone [Срок оценки: During each of the 8 rehabilitation sessions, over approximately 3 weeks]
  • Quadriceps Motor Latency [Срок оценки: During each of the 8 rehabilitation sessions, over approximately 3 weeks]
  • Maximal Quadriceps Surface Electromyography Activity [Срок оценки: At the beginning of each of the 8 rehabilitation sessions, over approximately 3 weeks]
  • Perceived Exertion Assessed Using the Borg Scale [Срок оценки: At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks]
  • Pain Intensity Assessed Using a Numeric Rating Scale [Срок оценки: At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie — Saint-Maurice

Идентификаторы

NCT: NCT07736625 · 2026-A00944-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗