NCT07736625

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

Surface ElectromyographyElectromyographyEMG BiofeedbackBiofeedbackQuadriceps MuscleQuadriceps ActivationArthrogenic Muscle InhibitionKnee RehabilitationKnee SurgeryMotor ControlNeuromuscular RehabilitationSingle-Case Experimental DesignSCED

Outcome Measures

Primary Outcomes (1)

  • Percentage Deviation From the Target Quadriceps Activation Level

    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

Secondary Outcomes (5)

  • 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

  • Perceived Exertion Assessed Using the Borg Scale

    At the end 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

Study Arms (2)

Visual sEMG Biofeedback

EXPERIMENTAL

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

Behavioral: Visual Surface EMG Biofeedback

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.

Behavioral: Standard Rehabilitation Without Visual Biofeedback

Interventions

Participants perform standardized rehabilitation exercises while receiving real-time visual feedback of quadriceps muscle activity using surface electromyography (sEMG)

Visual sEMG Biofeedback

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

No Visual Biofeedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie

Saint-Maurice, 94410, France

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Sylvain SB BELOT, MD

    Hôpitaux Paris Est Val-de-Marne (HPEVM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain SB BELOT, MD

CONTACT

Auriane AS SLAMA, ARC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each participant will complete both study conditions: four rehabilitation sessions with visual surface EMG biofeedback and four sessions without visual biofeedback. The order of the conditions will be randomized using a predefined balanced sequence. Each participant serves as his or her own control, allowing within-subject comparison of motor performance outcomes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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

Locations