A new clinical trial investigates prehabilitation with physiotherapy and mechanostimulation to reduce shoulder pain and improve mobility in patients undergoing latissimus dorsi flap breast reconstruction.
As of February 19, 2026, the record on ClinicalTrials.gov shows two study arms. One arm uses a structured prehabilitation program that combines physiotherapy with mechanostimulation before surgery, while the comparison arm receives no prehabilitation with mechanostimulation. The sponsor is Institut du Cancer de Montpellier – Val d’Aurelle. The trial is not yet recruiting. Observers will track postoperative shoulder pain and range of motion to determine if the prehabilitation approach can improve recovery while considering safety and device related performance under regulatory expectations.
The trial aims to evaluate the intended purpose of the intervention and whether the mechanism of action supports improved patient outcomes without compromising safety. Details about the specific device or equipment used for mechanostimulation are not disclosed in the public record.
What changed in care pathways?
The trial introduces a prehabilitation step before LD flap breast reconstruction. It merges physiotherapy with a mechanostimulation component. The aim is to determine if this prehab reduces shoulder pain and preserves or improves shoulder mobility after surgery. The public record lists two arms: with prehabilitation and without prehabilitation.
Arms and endpoints
The public record describes two arms. Arm A uses prehabilitation with physiotherapy and mechanostimulation. Arm B uses no prehabilitation with these elements. Specific endpoints are not fully disclosed in the public record, but shoulder pain and mobility are identified as key outcomes of interest.
Who is affected by this trial?
Population includes patients with breast cancer undergoing reconstruction with a latissimus dorsi flap. The record indicates the study is hosted by a French cancer center and not yet recruiting. Detailed eligibility criteria are not publicly disclosed in the current record.
How is the trial designed?
The entry lists two arms which differ by the use of prehabilitation with physiotherapy and mechanostimulation. The public record does not provide explicit details on randomization, blinding, sample size, or study duration. The not yet recruiting status confirms enrollment has not begun.
What could this mean for practice?
Should the trial demonstrate a reduction in postoperative shoulder pain and an improvement in mobility, prehabilitation could become part of the preoperative workflow for LD flap reconstruction. Regulators will weigh device performance and safety considerations under MDR guidance as part of a broader assessment of this approach. The public record does not include vendor statements; the sponsor is an academic institution.
What is the regulatory context?
The entry is registered on ClinicalTrials.gov as a not yet recruiting study. The sponsor is a recognized cancer institute in Montpellier. Outcomes will inform clinical practice and regulatory evaluation, pending peer reviewed results and any disclosures about the mechanostimulation device used.
- 1. Is this approved for routine practice? Not yet. It is an early phase trial not yet recruiting.
- 2. What is mechanostimulation in this context? It refers to mechanical stimulation applied during physiotherapy as part of the prehabilitation protocol.
- 3. Where can I find more information? The ClinicalTrials.gov link included below in the article.
- 4. What happens next if results are favorable? The trial would require peer review and regulatory assessment before adoption in standard care.
Takeaway: This trial represents a structured evaluation of a preoperative rehabilitation approach for LD flap reconstruction. Clinicians, device manufacturers, and regulators should monitor results as they unfold to inform practice and regulatory decisions.
Disclaimer: This article is intended for clinical and regulatory professionals. It is not legal advice and does not constitute regulatory guidance. Consult official MDR guidance and regulatory authorities for specific compliance questions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07418060?term=medical+device