Amputation, Amputation; Traumatic, Leg, Lower
Conditions
Keywords
lower limb, transtibial
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.
Interventions
DEVICEWRL TTP
evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ad hoc check-list Adverse Event | baseline | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System usability scale | baseline | a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with values 0-100 that assess the usability of the prosthesis |
| 10mwt - 10 meters walking test | day 2 | to assess the walking speed |
| SCT - stair climb test | day 2 | to assess the capability of climb 8 stairs |
| CR-10 Borg Scale | day 5 | 0-10 numerical rating scale that evaluate of the subjective perception of effort during walking |
| 6mwt - 6 minute walking test on the treadmill | day 4 | to assess the fatigue |
| Gait analisys | day 5 | to assess the gait pattern |
| TUG - Timed Up and GO | day 2 | to assess lower limb capability |
Countries
Italy
Outcome results
None listed