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Clinical Trials/NCT06161961
NCT06161961
Completed
Not Applicable

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

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country7 target enrollmentJuly 21, 2020
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ConditionsAmputationAmputation; Traumatic, Leg, Lower

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
7
Locations
1
Primary Endpoint
ad hoc check-list Adverse Event
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.
Registry
clinicaltrials.gov
Start Date
July 21, 2020
End Date
December 22, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudio Macchi

Full Professor

Fondazione Don Carlo Gnocchi Onlus

Eligibility Criteria

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.

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.

Secondary Outcomes

  • 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)
  • SCT - stair climb test(day 3)
  • 6mwt - 6 minute walking test on the treadmill(day 5)
  • Gait analisys(day 5)

Study Sites (1)

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