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

2026年8月17日 更新者: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

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

5

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Saint-Maurice、法国、94410
        • Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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)
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage Deviation From the Target Quadriceps Activation Level
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Time Spent Within the Target Quadriceps Activation Zone
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sylvain SB BELOT, MD、Hôpitaux Paris Est Val-de-Marne (HPEVM)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年7月24日

首先提交符合 QC 标准的

2026年7月24日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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