NCT07553013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 16, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 15, 2026

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Perceived pain and pain medication

    Throughout the 2 weeks intervention

Study Arms (2)

functional proprioceptive stimulations combined with continuous passive movement

EXPERIMENTAL
Device: functional proprioceptive stimulations combined with continuous passive movementDevice: continuous passive movement

continuous passive movement

ACTIVE COMPARATOR
Device: continuous passive movement

Interventions

5 days a week for 2 weeks

functional proprioceptive stimulations combined with continuous passive movement

5 days a week for 2 weeks

continuous passive movementfunctional proprioceptive stimulations combined with continuous passive movement

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Martin Sport

Marseille, 13000, France

Location

MeSH Terms

Interventions

Motion Therapy, Continuous Passive

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMusculoskeletal Manipulations

Study Officials

  • Serge S Colson, Professor

    Universite Cote d'Azur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 27, 2026

Study Start

June 16, 2025

Primary Completion

October 24, 2025

Study Completion

October 24, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations