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

Amputation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06161961
• Other study ID #: MOTU TT - studio clinico
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: December 22, 2022

Study information

• Verified date: November 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 22, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Amputation, Traumatic
• Amputation; Traumatic, Leg, Lower

Intervention

Device:
• WRL TTP
evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Firenze	FI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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. — View Citation

Borg, G. (1998). Borg's Perceived Exertion and Pain Scales. Human Kinetics.

Brooke, J. (1996). SUS: a

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ad hoc check-list Adverse Event	questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.	baseline
Primary	ad hoc check-list Adverse Event	questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.	day 2
Primary	ad hoc check-list Adverse Event	questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.	day 3
Primary	ad hoc check-list Adverse Event	questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.	day 4
Primary	ad hoc check-list Adverse Event	questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.	day 5
Secondary	CR-10 Borg Scale	0-10 numerical rating scale that evaluate of the subjective perception of effort during walking	day 5
Secondary	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
Secondary	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
Secondary	10mwt - 10 meters walking test	to assess the walking speed	day 2
Secondary	10mwt - 10 meters walking test	to assess the walking speed	day 3
Secondary	SCT - stair climb test	to assess the capability of climb 8 stairs	day 2
Secondary	SCT - stair climb test	to assess the capability of climb 8 stairs	day 3
Secondary	TUG - Timed Up and GO	to assess lower limb capability	day 2
Secondary	TUG - Timed Up and GO	to assess lower limb capability	day 3
Secondary	6mwt - 6 minute walking test on the treadmill	to assess the fatigue	day 4
Secondary	6mwt - 6 minute walking test on the treadmill	to assess the fatigue	day 5
Secondary	Gait analisys	to assess the gait pattern	day 5