Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders
- Conditions
- Musculoskeletal Disorder
- Registration Number
- NCT05926739
- Lead Sponsor
- Vivaltis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria:<br><br> - Adult patients (between 18 and 65 years of age);<br><br> - Patient presenting at least one of the following symptoms related to a locomotor<br> disorder of the knee and/or spine: pain, hypertonia, amyotrophy, mobility<br> restriction, muscle weakness, reduction or loss of motor control, reduction in motor<br> pattern, trophic anomaly;<br><br> - Patient able to make himself available to attend sessions regularly and is confident<br> of being able to complete all sessions; ;<br><br> - Patient who has signed the study participation consent form;y;<br><br> - Patient physically and mentally willing and able, according to the investigator's<br> judgment at the time of recruitment, to perform the procedures under study;<br><br> - Patient with social security coverage.<br><br>Exclusion Criteria:<br><br> - Patients with Stroke, Alzheimer's, multiple sclerosis, peripheral nervous system<br> disorders, spinal cord injury or with cognitive and/or behavioural disorders likely,<br> in the practitioner's judgement in the practitioner's judgement, interact with the<br> self-assessment or biofeedback;<br><br> - Patients with hypersensitivity to electrostimulation;<br><br> - Patients who, in the 1 month prior to inclusion, have had injections of<br> corticosteroids (e.g. hyaluronate) in the knee/spine concerned;<br><br> - Patients with an implanted pacemaker or spinal cord pacemaker;<br><br> - Pregnant at the time of the inclusion visit, or wishing to become pregnant during<br> the treatment period;<br><br> - Patients who have renounced their liberty by administrative or judicial sentence, or<br> under guardianship or limited judicial protection;<br><br> - Patient participating in another interventional clinical trial for the same<br> pathology or testing/having tested an investigational drug in the 30 days prior to<br> inclusion in the study;<br><br> - Patient unable to read or write French;
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee;Mean change in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine.
- Secondary Outcome Measures
Name Time Method