IRCCS Fondazione Don Carlo Gnocchi
Florence, FI, 50143, Italy
Completed
NCT Number: NCT06161961
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
WRL TTP
Deviceevaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype
Primary outcomes
-
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.
-
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
-
CR-10 Borg Scale
Time frame: day 5
0-10 numerical rating scale that evaluate of the subjective perception of effort during walking
-
System usability scale
Time frame: 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
-
System usability scale
Time frame: day 5
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
Time frame: day 2
to assess the walking speed
-
10mwt - 10 meters walking test
Time frame: day 3
to assess the walking speed
-
SCT - stair climb test
Time frame: day 2
to assess the capability of climb 8 stairs
-
SCT - stair climb test
Time frame: day 3
to assess the capability of climb 8 stairs
-
TUG - Timed Up and GO
Time frame: day 2
to assess lower limb capability
-
TUG - Timed Up and GO
Time frame: day 3
to assess lower limb capability
-
6mwt - 6 minute walking test on the treadmill
Time frame: day 4
to assess the fatigue
-
6mwt - 6 minute walking test on the treadmill
Time frame: day 5
to assess the fatigue
-
Gait analisys
Time frame: day 5
to assess the gait pattern
Sponsors and collaborators
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Other
Registry information
Official study title
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
Important dates
- Study start
- 2020
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Dec 8, 2023
- Registry last updated
- Dec 8, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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