Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Amputation, Amputation; Traumatic, Leg, Lower

Intervention / Treatment
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* Device: WRL TTP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prosthetic group<br>prosthetic group performs the entire protocol with the prosthesis prototype. | Device: WRL TTP<br>* evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | baseline | 
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 2 | 
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 3 | 
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 4 | 
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR-10 Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of effort during walking | day 5 | 
| System usability scale | 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 | baseline | 
| System usability scale | 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 | day 5 | 
| 10mwt - 10 meters walking test | to assess the walking speed | day 2 | 
| 10mwt - 10 meters walking test | to assess the walking speed | day 3 | 
| SCT - stair climb test | to assess the capability of climb 8 stairs | day 2 | 
| SCT - stair climb test | to assess the capability of climb 8 stairs | day 3 | 
| TUG - Timed Up and GO | to assess lower limb capability | day 2 | 
| TUG - Timed Up and GO | to assess lower limb capability | day 3 | 
| 6mwt - 6 minute walking test on the treadmill | to assess the fatigue | day 4 | 
| 6mwt - 6 minute walking test on the treadmill | to assess the fatigue | day 5 | 
| Gait analisys | to assess the gait pattern | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower limb, transtibial