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AmputationNCT06161961

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

A study testing WRL TTP in people with Amputation and Amputation; Traumatic, Leg, Lower, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Amputation, Amputation; Traumatic, Leg, Lower
What is being tested?
WRL TTP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteItaly
Study dates
21 Jul 2020to 22 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Fondazione Don Carlo Gnocchi

    Florence, FI, 50143

Other trials in Italy

About this study

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

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.
Being tested
WRL TTP
Keywords
lower limb, transtibial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WRL TTPDevice

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

Study groups in NCT06161961
Study groupRoleWhat they receive
prosthetic groupExperimentalprosthetic group performs the entire protocol with the prosthesis prototype.
Receives: Device: WRL TTP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ad hoc check-list Adverse Event

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

    Measured: baseline

  2. ad hoc check-list Adverse Event

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

    Measured: day 2

  3. ad hoc check-list Adverse Event

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

    Measured: day 3

  4. ad hoc check-list Adverse Event

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

    Measured: day 4

  5. ad hoc check-list Adverse Event

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

    Measured: day 5

Secondary outcomes (12)

  1. CR-10 Borg Scale

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

    Measured: 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

    Measured: 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

    Measured: day 5

  4. 10mwt - 10 meters walking test

    to assess the walking speed

    Measured: day 2

  5. 10mwt - 10 meters walking test

    to assess the walking speed

    Measured: day 3

  6. SCT - stair climb test

    to assess the capability of climb 8 stairs

    Measured: day 2

  7. SCT - stair climb test

    to assess the capability of climb 8 stairs

    Measured: day 3

  8. TUG - Timed Up and GO

    to assess lower limb capability

    Measured: day 2

  9. TUG - Timed Up and GO

    to assess lower limb capability

    Measured: day 3

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

    to assess the fatigue

    Measured: day 4

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

    to assess the fatigue

    Measured: day 5

  12. Gait analisys

    to assess the gait pattern

    Measured: day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start21 Jul 2020
  3. Primary completion10 Nov 2022
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161961
Sponsor's protocol ID
MOTU TT - studio clinico
Status last verified
Nov 2023
First submitted
8 Nov 2023
Last updated
8 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing WRL TTP in people with Amputation and Amputation; Traumatic, Leg, Lower, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ad hoc check-list Adverse Event (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06161961, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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