Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- ad hoc check-list Adverse Event
Study Overview
Brief Summary
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.
The main question it aims to answer are:
- Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
- Provide an indication of the functional effectiveness of the device and its satisfaction by patients.
Participants will perform:
- walking tests inside parallel bars on flat and/or inclined terrain;
- walking tests on treadmill;
- stair climbing/descent tests.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •trans femoural amputation
- •Medicare Functional Classification Levels k3-k4
- •expert prosthesis wearer (more than one year)
- •electronic knee prostheses user
- •energy-release prosthetic foot user
Exclusion Criteria
- •Relevant medical comorbidities
- •heart device wearers (PMK or AICD)
- •cognitive impairment
- •anxious or depressed illness
Arms & Interventions
prosthetic group
prosthetic group performs the entire protocol with the prosthesis prototype.
Intervention: WRL ATP (Device)
Outcomes
Primary Outcomes
ad hoc check-list Adverse Event
Time Frame: day 5
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: baseline
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: day 2
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: day 3
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: day 4
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Secondary Outcomes
No secondary outcomes reported
Investigators
Claudio Macchi
Full Professor
Fondazione Don Carlo Gnocchi Onlus