Effects of Early Rehabilitation Using Blood Flow Restriction and/or Surface Electromyography Biofeedback on Quadriceps Activation and Strength After Anterior Cruciate Ligament Reconstruction: A Multicenter Randomized Controlled Trial
NCT ID: NCT07145606
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2026-01-02
2031-01-02
Brief Summary
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AMIRACL is a multicenter, prospective, randomized, controlled, parallel-group trial with four arms enrolling 200 adults (18-35 years) undergoing a first-time ACL reconstruction. Participants are randomized with center stratification; outcome assessors are blinded to allocation. The four groups are: (1) standard rehabilitation; (2) standard + early BFR; (3) standard + early sEMG biofeedback; and (4) standard + combined BFR and sEMG biofeedback. Interventions begin about 2 weeks postoperatively, are delivered over 6 weeks at three supervised sessions per week, and are integrated into contemporary ACL rehabilitation. BFR uses individualized, auto-regulated cuff pressure during low-load isometric and then dynamic exercises. sEMG biofeedback provides real-time visual and/or auditory feedback to optimize quadriceps recruitment during targeted tasks. The combined arm receives both modalities concurrently.
The primary objective is to compare quadriceps activation (sEMG) and maximal isometric knee extensor strength between groups at 3 and 6 months. Secondary objectives include return-to-sport readiness and patient-reported function (e.g., ACL-RSI, IKDC), broader knee outcomes (e.g., KOOS, Lysholm), adherence and adverse events across arms, and ACL re-injury (ipsilateral graft rupture or contralateral ACL injury) within 2 years. Longer-term patient-reported quality of life is explored up to 5 years.
Key eligibility criteria include age 18-35 years, first ACL reconstruction, and preinjury sport participation; major exclusions include revision ACL surgery, concomitant multi-ligament repair, neuromuscular disorders, and contraindications to BFR or sEMG. The planned sample size is 200 (50 per arm), powered to detect a clinically meaningful between-group difference in quadriceps activation. Analyses will follow the intention-to-treat principle using mixed-effects models for repeated measures. The study is conducted under Good Clinical Practice and applicable Swiss regulations; all participants provide written informed consent. Overall, AMIRACL will determine whether early BFR, sEMG biofeedback, or their combination meaningfully improves quadriceps activation, strength, and clinical recovery after ACL reconstruction compared with standard rehabilitation alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Rehabilitation
Participants receive the standardized postoperative ACL rehabilitation program only. Sessions are supervised approximately 3 times per week for 6 weeks, starting about 2 weeks after surgery. Content includes progressive range of motion, quadriceps activation and strengthening, functional tasks, and return-to-activity progressions delivered per protocol.
Standard Rehabilitation
Standardized postoperative ACL rehabilitation only. Begins \~2 weeks after surgery; supervised \~3 sessions/week for 6 weeks. Includes progressive range of motion, quadriceps activation/strengthening, functional drills, and return-to-activity progressions delivered per protocol.
Standard Rehabilitation + Blood Flow Restriction (BFR)
Participants receive the standardized postoperative ACL rehabilitation plus low-load BFR training. BFR is applied with individualized limb occlusion pressure during prescribed isometric and then dynamic exercises. Sessions are supervised \~3 times per week for 6 weeks beginning \~2 weeks postoperatively.
Blood Flow Restriction (BFR) Training
Low-load resistance exercises performed with individualized limb occlusion pressure (LOP) determined each session; target %LOP per protocol. Progresses from isometric to dynamic open/closed-chain tasks. Delivered under supervision \~3 sessions/week for 6 weeks; monitoring of tolerance and adverse events per safety LOP.
Standard Rehabilitation + sEMG Biofeedback
Participants receive the standardized postoperative ACL rehabilitation plus surface EMG biofeedback to optimize quadriceps recruitment during targeted tasks (e.g., isometric contractions and functional movements). Real-time visual and/or auditory feedback is provided during supervised sessions \~3 times per week for 6 weeks starting \~2 weeks after surgery.
sEMG Biofeedback
Real-time surface electromyography biofeedback to optimize quadriceps recruitment during targeted tasks (e.g., isometric contractions, straight-leg raise, sit-to-stand, mini-squat, gait drills). Visual and/or auditory feedback with progressive targets. Supervised \~3 sessions/week for 6 weeks; outcome assessors remain blinded.
Standard Rehabilitation + Combined BFR and sEMG Biofeedback
Participants receive the standardized postoperative ACL rehabilitation with both adjuncts delivered concurrently: individualized low-load BFR training and sEMG biofeedback during targeted tasks. Sessions are supervised \~3 times per week for 6 weeks beginning \~2 weeks postoperatively.
Blood Flow Restriction (BFR) Training
Low-load resistance exercises performed with individualized limb occlusion pressure (LOP) determined each session; target %LOP per protocol. Progresses from isometric to dynamic open/closed-chain tasks. Delivered under supervision \~3 sessions/week for 6 weeks; monitoring of tolerance and adverse events per safety LOP.
sEMG Biofeedback
Real-time surface electromyography biofeedback to optimize quadriceps recruitment during targeted tasks (e.g., isometric contractions, straight-leg raise, sit-to-stand, mini-squat, gait drills). Visual and/or auditory feedback with progressive targets. Supervised \~3 sessions/week for 6 weeks; outcome assessors remain blinded.
Interventions
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Standard Rehabilitation
Standardized postoperative ACL rehabilitation only. Begins \~2 weeks after surgery; supervised \~3 sessions/week for 6 weeks. Includes progressive range of motion, quadriceps activation/strengthening, functional drills, and return-to-activity progressions delivered per protocol.
Blood Flow Restriction (BFR) Training
Low-load resistance exercises performed with individualized limb occlusion pressure (LOP) determined each session; target %LOP per protocol. Progresses from isometric to dynamic open/closed-chain tasks. Delivered under supervision \~3 sessions/week for 6 weeks; monitoring of tolerance and adverse events per safety LOP.
sEMG Biofeedback
Real-time surface electromyography biofeedback to optimize quadriceps recruitment during targeted tasks (e.g., isometric contractions, straight-leg raise, sit-to-stand, mini-squat, gait drills). Visual and/or auditory feedback with progressive targets. Supervised \~3 sessions/week for 6 weeks; outcome assessors remain blinded.
Eligibility Criteria
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Inclusion Criteria
First-time anterior cruciate ligament (ACL) reconstruction.
Pre-injury activity level Tegner ≥ 6.
Marx activity scale ≥ 12.
Body mass index \< 35.
With or without associated meniscal injury.
Exclusion Criteria
Concurrent repair of other knee ligaments.
Neurological or systemic musculoskeletal disorders.
Contraindications to blood flow restriction (BFR) or surface EMG monitoring/biofeedback.
Pregnancy or lactation.
Language barrier or cognitive impairment preventing valid informed consent; vulnerable populations not enrolled.
18 Years
35 Years
ALL
No
Sponsors
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Haute Ecole ARC Sante
OTHER
Responsible Party
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Forelli Florian
Assistant Professor ; PhD
Locations
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Orthosport
Domont, , France
Movare
Bulle, , Switzerland
Centre de l'Appareil Locomoteur et du Sport, Hôpitaux Universitaires de Genève (HUG)
Geneva, , Switzerland
Exotherapie
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AMIRACL
Identifier Type: -
Identifier Source: org_study_id
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