Assessing the Usability and Reliability of the Prototype Prosthesis Devices
- Conditions
- AmputationTraumatic AmputationsLeg Amputation
- Interventions
- Device: prototype prosthetic group
- Registration Number
- NCT06616402
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description prosthetic group performs the entire protocol with the prosthesis prototype. prototype prosthetic group -
- Primary Outcome Measures
Name Time Method Ad hoc check list for Adverse Event day 6 questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
- Secondary Outcome Measures
Name Time Method Borg Scale day 5 0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
10mwt - 10 meters walking test day 4 to evaluate walking capacity measured in seconds
6mwt - 6 minutes walking test day 6 to evaluate walking capacity measured in metres
System Usability Scale day 6. a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with 0-100 that assesses the usability of the prosthesis.
TUG - Time Up and Go day 4 to assess lower limb capabilities in seconds
SCT - Stair Climbing Test day 4 to assess the capabilities of climb 8 stairs in seconds
FCT - Functional Reach Test baseline to assess the balance in centimeters
Functional Reach Test day 5 to assess the balance in centimeters
Cost of Transport -COT day 6 To assess metabolic consumption
Trial Locations
- Locations (1)
IRCCS Fondazione Don Carlo Gnocchi
🇮🇹Florence, FI, Italy