Interventional Pilot Study on the Evaluation of Functionality, Degree of Safety and Reliability of a New Robotic Prosthesis for Treatment of Transtibial Lower Limb Amputations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 7
- 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-tibial 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-tibial lower limb amputation;
- •Medicare functional classification: Level K3-K4;
- •Subjects who have worn prostheses for at least 1 year (experienced wearers);
- •Use of prosthesis with energy-returning prosthetic foot.
Exclusion Criteria
- •Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
- •Wearers of implantable cardiac medical devices (PMK or AICD);
- •Cognitive impairment (MMSE corrected for age and education <24);
- •Inability or unavailability to provide informed consent;
- •Severe depressive and/or anxious symptoms.
Arms & Interventions
prosthetic group
prosthetic group performs the entire protocol with the prosthesis prototype.
Intervention: WRL TTP (Device)
Outcomes
Primary Outcomes
ad hoc check-list Adverse Event
Time Frame: day 5
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: baseline
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: day 2
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: day 3
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time Frame: day 4
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
Secondary Outcomes
- SCT - stair climb test(day 3)
- TUG - Timed Up and GO(day 3)
- CR-10 Borg Scale(day 5)
- System usability scale(day 5)
- 10mwt - 10 meters walking test(day 3)
- 6mwt - 6 minute walking test on the treadmill(day 5)
- Gait analisys(day 5)
- System usability scale(baseline)
- 10mwt - 10 meters walking test(day 2)
- SCT - stair climb test(day 2)
- TUG - Timed Up and GO(day 2)
- 6mwt - 6 minute walking test on the treadmill(day 4)
Investigators
Claudio Macchi
Full Professor
Fondazione Don Carlo Gnocchi Onlus