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CompletedNCT06284005MOTU-ATPUpdated Sep 19, 2024

Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level

An interventional study of WRL ATP in Amputation, Traumatic Amputation and Leg Injury, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

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

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Jul 2020, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
4
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-femoral 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
  • Traumatic Amputation
  • Leg Injury
  • Lower Limb Injury

Keywords

  • lower limb
  • transfemoral
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 4 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.

Browse Fondazione Don Carlo Gnocchi Onlus studies →

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 femoural amputation
  • Medicare Functional Classification Levels k3-k4
  • expert prosthesis wearer (more than one year)
  • electronic knee prostheses user
  • energy-release prosthetic foot user

Exclusion criteria

Exclusion Criteria:

  • Relevant medical comorbidities
  • heart device wearers (PMK or AICD)
  • cognitive impairment
  • anxious or depressed illness
05

Study design

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

Study arms

  • Experimental
    prosthetic group

    prosthetic group performs the entire protocol with the prosthesis prototype.

    Device: WRL ATP

Interventions

  • DeviceWRL ATP

    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 feasibility of the prosthesis and description of any adverse events.

    Time frame: baseline

  2. ad hoc check-list Adverse Event

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

    Time frame: day 5

07

Study locations

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

References and documents

Publications

  • 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 ↗
  • 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 ↗
  • 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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06284005
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Responsible party
Claudio Macchi (Full Professor, Fondazione Don Carlo Gnocchi Onlus) — Principal investigator
First posted
Feb 28, 2024
Start date
Jul 27, 2020
Primary completion
Nov 10, 2022
Completion
Dec 22, 2022
Last update
Sep 19, 2024

Study contacts

claudio macchi
principal investigator · IRCCS Fondazione Don Carlo Gnocchi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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