- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07736625
Effect of Surface EMG Biofeedback on Quadriceps Inhibition Release During Postoperative Knee Rehabilitation (BIOQUAD)
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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sylvain SB BELOT, MD
- Telefonní číslo: 01 43 96 63 83
- E-mail: sylvain.belot@ght94n.fr
Studijní záloha kontaktů
- Jméno: Auriane AS SLAMA, ARC
- Telefonní číslo: +33607317969
- E-mail: auriane.slama@ght94n.fr
Studijní místa
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Saint-Maurice, Francie, 94410
- Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie
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Kontakt:
- Sylvain SB BELOT, MD
- Telefonní číslo: 0607317969
- E-mail: sylvain.belot@ght94n.fr
-
Kontakt:
- Auriane AS Auriane, ARC
- E-mail: auriane.slama@ght94n.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Visual sEMG Biofeedback
Participants perform standardized rehabilitation exercises with real-time visual surface electromyography biofeedback.
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Participants perform standardized rehabilitation exercises while receiving real-time visual feedback of quadriceps muscle activity using surface electromyography (sEMG)
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Aktivní komparátor: No Visual Biofeedback
Participants perform the same standardized rehabilitation exercises without visual biofeedback.
Surface EMG signals are recorded but not displayed to the participant.
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Participants perform the same standardized rehabilitation exercises without visual biofeedback.
Surface electromyography signals are recorded but are not displayed to the participant.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage Deviation From the Target Quadriceps Activation Level
Časové okno: During each of the 8 rehabilitation sessions, over approximately 3 weeks
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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.
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During each of the 8 rehabilitation sessions, over approximately 3 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time Spent Within the Target Quadriceps Activation Zone
Časové okno: During each of the 8 rehabilitation sessions, over approximately 3 weeks
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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.
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During each of the 8 rehabilitation sessions, over approximately 3 weeks
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Quadriceps Motor Latency
Časové okno: During each of the 8 rehabilitation sessions, over approximately 3 weeks
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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.
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During each of the 8 rehabilitation sessions, over approximately 3 weeks
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Maximal Quadriceps Surface Electromyography Activity
Časové okno: At the beginning of each of the 8 rehabilitation sessions, over approximately 3 weeks
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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
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At the beginning of each of the 8 rehabilitation sessions, over approximately 3 weeks
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Pain Intensity Assessed Using a Numeric Rating Scale
Časové okno: At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
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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.
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At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
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Perceived Exertion Assessed Using the Borg Scale
Časové okno: At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
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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.
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At the end of each of the 8 rehabilitation sessions, over approximately 3 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Sylvain SB BELOT, MD, Hôpitaux Paris Est Val-de-Marne (HPEVM)
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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