AmputationMOTU-ATPNCT06284005
Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level
A study testing WRL ATP in people with Amputation and Traumatic Amputation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amputation, Traumatic Amputation, Leg Injury
- What is being tested?
- WRL ATP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- 27 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 femoural amputation
- Medicare Functional Classification Levels k3-k4
- expert prosthesis wearer (more than one year)
- electronic knee prostheses user
- energy-release prosthetic foot user
Who cannot join
- Relevant medical comorbidities
- heart device wearers (PMK or AICD)
- cognitive impairment
- anxious or depressed illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level
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.
- Conditions
- Amputation, Traumatic Amputation, Leg Injury, Lower Limb Injury
- Being tested
- WRL ATP
- Keywords
- lower limb, transfemoral
- Medical subject headings
- Amputation, Traumatic, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WRL ATPDevice
evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype
| Study group | Role | What they receive |
|---|---|---|
| prosthetic group | Experimental | prosthetic group performs the entire protocol with the prosthesis prototype. Receives: Device: WRL ATP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: baseline
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 2
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 3
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 4
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start27 Jul 2020
- Primary completion10 Nov 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Macchi, Fondazione Don Carlo Gnocchi ETS
- Investigators
- claudio macchi, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284005
- Sponsor's protocol ID
- MOTU ATP - Studio clinico
- Acronym
- MOTU-ATP
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18566923Mak 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 11392649Pirouzi 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 25197716Segal 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level
- ClinicalTrials.gov ID
- NCT06284005
- Acronym / sponsor ID
- MOTU-ATP / MOTU ATP - Studio clinico
- Conditions
- Amputation, Traumatic Amputation, Leg Injury, Lower Limb Injury
- Keywords
- lower limb, transfemoral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prosthetic group | Experimental | Device: WRL ATPprosthetic group performs the entire protocol with the prosthesis prototype. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Relevant medical comorbidities
- heart device wearers (PMK or AICD)
- cognitive impairment
- anxious or depressed illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WRL ATPevaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype | Device | prosthetic group |
Primary outcome
ad hoc check-list Adverse Event
Time frame: baseline
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time frame: day 2
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time frame: day 3
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time frame: day 4
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
Time frame: day 5
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 18566923Gailey 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.
- Background: PubMed 11392649Mak 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.
- Background: PubMed 25197716Pirouzi 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.
- Background: PubMed 17436172Segal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
claudio macchi principal investigator
IRCCS Fondazione Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WRL ATP in people with Amputation and Traumatic Amputation, 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 5 inclusion and 4 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 19 Sep 2024. 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 NCT06284005, which also lists 4 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 19 Sep 2024.