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

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

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 Overview

• Status: Completed
• Conditions: Amputation; Amputation; Traumatic, Leg, Lower
• Intervention / Treatment: Device: WRL TTP

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • FI
    • Firenze, FI, Italy, 50143
      • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

General Publications

• Huang S, Huang H. Voluntary Control of Residual Antagonistic Muscles in Transtibial Amputees: Reciprocal Activation, Coactivation, and Implications for Direct Neural Control of Powered Lower Limb Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2019 Jan;27(1):85-95. doi: 10.1109/TNSRE.2018.2885641. Epub 2018 Dec 7.
• Au SK, Herr H, Weber J, Martinez-Villalpando EC. Powered ankle-foot prosthesis for the improvement of amputee ambulation. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:3020-6. doi: 10.1109/IEMBS.2007.4352965.
• Buckley JG, O'Driscoll D, Bennett SJ. Postural sway and active balance performance in highly active lower-limb amputees. Am J Phys Med Rehabil. 2002 Jan;81(1):13-20. doi: 10.1097/00002060-200201000-00004.
• Borg, G. (1998). Borg's perceived exertion and pain scales. Human Kinetics.
• Brooke, J. (1996). SUS: A
• Cherelle P, Grosu V, Matthys A, Vanderborght B, Lefeber D. Design and Validation of the Ankle Mimicking Prosthetic (AMP-) Foot 2.0. IEEE Trans Neural Syst Rehabil Eng. 2014 Jan;22(1):138-48. doi: 10.1109/TNSRE.2013.2282416. Epub 2013 Oct 7.
• Eslamy, M., Grimmer, M., & Seyfarth, A. (2012). Effects of Unidirectional Parallel Springs on Required Peak Power and Energy in Powered Prosthetic Ankles: Comparison between Different Active Actuation Concepts. Proceedings of the 2012 IEEE International Conference on Robotics and Biomimetics, December 11-14, Guangzhou, China.
• Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
• Grimmer, M., & Seyfarth, A. (2014). Mimicking human-like leg function in prosthetic limbs. In Neurorobotics: from brain machine interfaces to rehabilitation robotics. Berlin: Springer.
• Grimmer, M., Eslamy, M., & Seyfarth, A. (2014). Energetic and Peak Power Advantages of Series Elastic Actuators in an Actuated Prosthetic Leg for Walking and Running. Actuators, 3:1-19.
• Mak AF, Zhang M, Boone DA. State-of-the-art research in lower-limb prosthetic biomechanics-socket interface: a review. J Rehabil Res Dev. 2001 Mar-Apr;38(2):161-74.
• Marino, M., Pattni, S., Greenberg, M., Miller, A., Hocker, E., Ritter, S., et al. (2015). Access to prosthetic devices in developing countries: Pathways and challenges. 2015 IEEE Global Humanitarian Technology Conference (GHTC), 45-51.
• Pirouzi G, Abu Osman NA, Eshraghi A, Ali S, Gholizadeh H, Wan Abas WA. Review of the socket design and interface pressure measurement for transtibial prosthesis. ScientificWorldJournal. 2014;2014:849073. doi: 10.1155/2014/849073. Epub 2014 Aug 13.
• Segal AD, Orendurff MS, Klute GK, McDowell ML, Pecoraro JA, Shofer J, Czerniecki JM. Kinematic and kinetic comparisons of transfemoral amputee gait using C-Leg and Mauch SNS prosthetic knees. J Rehabil Res Dev. 2006 Nov-Dec;43(7):857-70. doi: 10.1682/jrrd.2005.09.0147.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: lower limb; transtibial
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: MOTU TT - studio clinico

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No