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临床试验/NCT07736625
NCT07736625尚未招募不适用

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

Hopitaux de Saint-Maurice1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5
试验地点
1
主要终点
Percentage Deviation From the Target Quadriceps Activation Level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Visual sEMG Biofeedback

Experimental

Participants perform standardized rehabilitation exercises with real-time visual surface electromyography biofeedback.

干预措施: Visual Surface EMG Biofeedback (Behavioral)

No Visual Biofeedback

Active Comparator

Participants perform the same standardized rehabilitation exercises without visual biofeedback. Surface EMG signals are recorded but not displayed to the participant.

干预措施: Standard Rehabilitation Without Visual Biofeedback (Behavioral)

结局指标

主要结局

Percentage Deviation From the Target Quadriceps Activation Level

时间窗: 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.

次要结局

  • Time Spent Within the Target Quadriceps Activation Zone(During each of the 8 rehabilitation sessions, over approximately 3 weeks)
  • Quadriceps Motor Latency(During each of the 8 rehabilitation sessions, over approximately 3 weeks)
  • Maximal Quadriceps Surface Electromyography Activity(At the beginning of each of the 8 rehabilitation sessions, over approximately 3 weeks)
  • Pain Intensity Assessed Using a Numeric Rating Scale(At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks)
  • Perceived Exertion Assessed Using the Borg Scale(At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks)

研究者

发起方
Hopitaux de Saint-Maurice
申办方类型
Other
责任方
Sponsor

研究点 (1)

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