Anterior Cruciate Ligament Reconstruction RehabilitationNCT07553013
Functional Proprioceptive Stimulation and Continuous Passive Motion Rehabilitation Interventions After Anterior Cruciate Ligament Reconstruction
A study testing functional proprioceptive stimulations combined with continuous passive movement and continuous passive movement in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universite Cote d'Azur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- functional proprioceptive stimulations combined with continuous passive movement and continuous passive movement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2025to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- functional proprioceptive stimulations combined with continuous passive movement, continuous passive movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional proprioceptive stimulations combined with continuous passive movementDevice
5 days a week for 2 weeks
continuous passive movementDevice
5 days a week for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| functional proprioceptive stimulations combined with continuous passive movement | Experimental | Not described Receives: Device: functional proprioceptive stimulations combined with continuous passive movement; Device: continuous passive movement |
| continuous passive movement | Active comparator | Not described Receives: Device: continuous passive movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at 2 weeks
Secondary outcomes (1)
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".
Measured: Throughout the 2 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start16 Jun 2025
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite Cote d'Azur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge Colson, Universite Cote d'Azur
- Investigators
- Serge S Colson, Professor, Principal investigator, Universite Cote d'Azur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553013
- Sponsor's protocol ID
- IRB00012476-2025-04-04-397
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Collado H, Tourtel PY, Bardot T, Fraysse T, Paul E, Prats M, Chorin F, Colson SS. Functional proprioceptive stimulation promotes early rehabilitation following ACL reconstruction: a randomized controlled trial. Front Rehabil Sci. 2026 Jul 16;7:1882498. doi: 10.3389/fresc.2026.1882498. eCollection 2026.
PubMed 42534953
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bénéfices de la Synchronisation Des Stimulations Proprioceptives Fonctionnelles (FPS) Avec la thérapie Par Mouvements Passifs Continus (CPM) après Reconstruction du Ligament croisé antérieur (RLCA).
- ClinicalTrials.gov ID
- NCT07553013
- Acronym / sponsor ID
- IRB00012476-2025-04-04-397
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universite Cote d'AzurUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional proprioceptive stimulations combined with continuous passive movement | Experimental | Device: functional proprioceptive stimulations combined with continuous passive movement, Device: continuous passive movement |
| continuous passive movement | Active comparator | Device: continuous passive movement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional proprioceptive stimulations combined with continuous passive movement5 days a week for 2 weeks | Device | functional proprioceptive stimulations combined with continuous passive movement |
| continuous passive movement5 days a week for 2 weeks | Device | continuous passive movement, functional proprioceptive stimulations combined with continuous passive movement |
Primary outcome
Active and passive range of motion
Time frame: From enrollment to the end of intervention at 2 weeks
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.
1 secondary outcome
Perceived pain and pain medication
Time frame: Throughout the 2 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42534953Collado H, Tourtel PY, Bardot T, Fraysse T, Paul E, Prats M, Chorin F, Colson SS. Functional proprioceptive stimulation promotes early rehabilitation following ACL reconstruction: a randomized controlled trial. Front Rehabil Sci. 2026 Jul 16;7:1882498. doi: 10.3389/fresc.2026.1882498. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge S Colson, Professor principal investigator
Universite Cote d'Azur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional proprioceptive stimulations combined with continuous passive movement and continuous passive movement in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universite Cote d'Azur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active and passive range of motion (time frame: From enrollment to the end of intervention at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.