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CompletedNCT06161961Updated Dec 8, 2023

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

An interventional study of WRL TTP in Amputation and Amputation; Traumatic, Leg, Lower, sponsored by Fondazione Don Carlo Gnocchi ETS. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Fondazione Don Carlo Gnocchi ETS · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jul 2020, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Amputation
  • Amputation; Traumatic, Leg, Lower

Browse trials for

Keywords

  • lower limb
  • transtibial
03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's enrollment of 7 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 43 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ( corrected for age and education \<24);
  • Inability or unavailability to provide ;
  • Severe depressive and/or anxious symptoms.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    prosthetic group

    prosthetic group performs the entire protocol with the prosthesis prototype.

    Device: WRL TTP

Interventions

  • DeviceWRL TTP

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

06

What researchers measure

Primary outcomes

  1. ad hoc check-list Adverse Event

    questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.

    Time frame: baseline

  2. ad hoc check-list Adverse Event

    questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.

    Time frame: day 2

  3. ad hoc check-list Adverse Event

    questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.

    Time frame: day 3

  4. ad hoc check-list Adverse Event

    questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.

    Time frame: day 4

  5. ad hoc check-list Adverse Event

    questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.

    Time frame: day 5

Secondary outcomes

  1. CR-10 Borg Scale

    0-10 numerical rating scale that evaluate of the subjective perception of effort during walking

    Time frame: day 5

  2. 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

    Time frame: baseline

  3. 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

    Time frame: day 5

  4. 10mwt - 10 meters walking test

    to assess the walking speed

    Time frame: day 2

  5. 10mwt - 10 meters walking test

    to assess the walking speed

    Time frame: day 3

  6. SCT - stair climb test

    to assess the capability of climb 8 stairs

    Time frame: day 2

  7. SCT - stair climb test

    to assess the capability of climb 8 stairs

    Time frame: day 3

  8. TUG - Timed Up and GO

    to assess lower limb capability

    Time frame: day 2

  9. TUG - Timed Up and GO

    to assess lower limb capability

    Time frame: day 3

  10. 6mwt - 6 minute walking test on the treadmill

    to assess the fatigue

    Time frame: day 4

  11. 6mwt - 6 minute walking test on the treadmill

    to assess the fatigue

    Time frame: day 5

  12. Gait analisys

    to assess the gait pattern

    Time frame: day 5

07

Study locations

1 site
  • IRCCS Fondazione Don Carlo Gnocchi
    Florence, FI 50143, Italy
08

References and documents

Publications

  • 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. PubMed 18002631 ↗
  • 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. PubMed 11807327 ↗
  • 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. PubMed 24122571 ↗
  • 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. PubMed 18566923 ↗
  • 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. PubMed 30530332 ↗
  • 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. PubMed 11392649 ↗
  • 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. PubMed 25197716 ↗
  • 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. PubMed 17436172 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Nov 2022, 27 months.

Of 38 non-industry interventional studies with no phase under Amputation, Traumatic, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's 27 months is below that.

Counting every sponsor, half of 46 studies reached it within 27 months; a quarter within 14 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2023
First posted
Dec 8, 2023
StartActual
Jul 21, 2020
Primary completionActual
Nov 10, 2022
CompletionActual
Dec 22, 2022
Last update
Dec 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06161961
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Responsible party
Claudio Macchi (Full Professor, Fondazione Don Carlo Gnocchi ETS) — Principal investigator
First posted
Dec 8, 2023
Start date
Jul 21, 2020
Primary completion
Nov 10, 2022
Completion
Dec 22, 2022
Last update
Dec 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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