Functional Proprioceptive Stimulation and Continuous Passive Motion Rehabilitation Interventions After Anterior Cruciate Ligament Reconstruction

Bénéfices de la Synchronisation Des Stimulations Proprioceptives Fonctionnelles (FPS) Avec la thérapie Par Mouvements Passifs Continus (CPM) après Reconstruction du Ligament croisé antérieur (RLCA).

The goal of this trial is to test if functional proprioceptive stimulations combined with continuous passive movement is more efficient than continuous passive movement alone to recover knee joint mobility after anterior cruciate ligament reconstruction in adults. It will also learn about the influence of functional proprioceptive stimulations on pain and pain medication. The main questions it aims to answer are:

• Does functional proprioceptive stimulations combined with continuous passive movement increase knee joint mobility more than continuous passive movement alone?
• Does functional proprioceptive stimulations combined with continuous passive movement reduce perceived pain and pain medication use more than continuous passive movement alone? Researchers will compare functional proprioceptive stimulations combined with continuous passive movement to continuous passive movement alone to see if functional proprioceptive stimulations combined with continuous passive movement is more efficient than continuous passive movement alone.

Participants will:

• Follow a supervised rehabilitation intervention comprising functional proprioceptive stimulations combined with continuous passive movement or continuous passive movement alone during five days a week for 2 weeks
• Attend the clinic five days a week for 2 weeks for rehabilitation, checkups and assessments

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
• Intervention / Treatment: Device: functional proprioceptive stimulations combined with continuous passive movement; Device: continuous passive movement

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13000
    • Clinique Saint-Martin Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• participants with isolated ACL rupture
• ACL reconstructed with a four-stranded semitendinosus or ex-tra-articular tenodesis autograft
• enrollment in the rehabilitation program between the fourth and seventh postoperative day

Exclusion Criteria:

• previous ligament reconstruction of the involved knee, reconstruction using quadriceps or patellar tendon autograft
• presence of major neurological or musculoskeletal disorders (e.g., multiple trauma, Parkinson's disease, cerebral palsy, stroke, Alzheimer's disease, dementia…)
• presence of cognitive impairment (i.e., Mini Mental State Examination score < 18)
• body mass index greater than 35 kg/m².

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: functional proprioceptive stimulations combined with continuous passive movement	Device: functional proprioceptive stimulations combined with continuous passive movement; 5 days a week for 2 weeks; Device: continuous passive movement; 5 days a week for 2 weeks
Active Comparator: continuous passive movement	Device: continuous passive movement; 5 days a week for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active and passive range of motion	Active and passive range of motion of the knee joint (in degrees; °) will be assessed with a 30-cm long manual goniometer at the end of the first session, the fifth and the last rehabilitation session of the 2 weeks intervention.	From enrollment to the end of intervention at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived pain and pain medication	Pain intensity will be assessed using a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at the beginning and at the end of each rehabilitation session (n = 10). Participants will reported daily intake of analgesic medication throughout the two-week rehabilitation period by simpling answering "YES" or "NO".	Throughout the 2 weeks intervention

Collaborators and Investigators

• Sponsor: Universite Cote d'Azur
• Investigators: Principal Investigator: Serge S Colson, Professor, Université Cote d'Azur

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Actual): October 24, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Musculoskeletal Manipulations; Motion Therapy, Continuous Passive
• Other Study ID Numbers: IRB00012476-2025-04-04-397

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No