NCT06161961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

November 8, 2023

Last Update Submit

November 30, 2023

Conditions

AmputationAmputation; Traumatic, Leg, Lower

Keywords

lower limbtranstibial

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (12)

  • CR-10 Borg Scale

    day 5

  • System usability scale

    baseline

  • System usability scale

    day 5

  • 10mwt - 10 meters walking test

    day 2

  • 10mwt - 10 meters walking test

    day 3

  • +7 more secondary outcomes

Study Arms (1)

prosthetic group

EXPERIMENTAL

prosthetic group performs the entire protocol with the prosthesis prototype.

Device: WRL TTP

Interventions

WRL TTPDEVICE

evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype

prosthetic group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Location

Related 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.

    PMID: 18002631BACKGROUND

  • 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.

    PMID: 11807327BACKGROUND

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

    BACKGROUND

  • Brooke, J. (1996). SUS: a

    BACKGROUND

  • 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.

    PMID: 24122571BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 18566923BACKGROUND

  • Grimmer, M., & Seyfarth, A. (2014). Mimicking human-like leg function in prosthetic limbs. In Neurorobotics: from brain machine interfaces to rehabilitation robotics. Berlin: Springer.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30530332BACKGROUND

  • 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.

    PMID: 11392649BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 25197716BACKGROUND

  • 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.

    PMID: 17436172BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 8, 2023

First Posted

December 8, 2023

Study Start

July 21, 2020

Primary Completion

November 10, 2022

Study Completion

December 22, 2022

Last Updated

December 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)