Assessing the Usability and Reliability of the Prototype Prosthesis Devices (MOTU++)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Traumatic Amputations; Amputation; Leg Amputation

Treatments: Device: prototype prosthetic group

Study type: Interventional

Funder types: Other

Identifiers

NCT06616402

CP-PAI-02-23

Details and patient eligibility

About

The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 80 years;
• Lower limb amputation at the transfemoral or transtibial level;
• Functional medical classification: Level K3-K4 [25];
• Subjects wearing a prosthesis for at least 1 year (experienced wearers);
• Maximum body weight 100 kg.

Exclusion criteria

• Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
• Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
• Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
• Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
• Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
• Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

prosthetic group performs the entire protocol with the prosthesis prototype.

Other group

Treatment:

Device: prototype prosthetic group