Lower Limb AmputationMOTU++ pedaneNCT06883942
Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
An observational study of Lower Limb Amputation and Slip Perturbations, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation, Slip Perturbations, Fall Risk
- What is being tested?
- prosthetic group performs the entire protocol with their own prosthesis and Experimental Group
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 6 Feb 2024to 17 Jul 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects with monolateral trans-femoral and/or trans-tibial.
Who may be able to join
- Trans-femoral or trans-tibial lower limb amputation;
- Functional medical classification: Level K3-K4;
- Subjects who have had a prosthesis for at least 1 year (experienced wearers);
- Informed consent signed by the subject
Who cannot join
- Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits);
- Cardiac device wearers (PMK or AICD);
- Cognitive impairment (MMSE adjusted for age and schooling <24);
- Inability or unwillingness to provide informed consent;
- Severe depressive symptomatology - Beck Depression Inventory (BDI-II <19);
- Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y <50).
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation
Read the detailed description
The protocol will involve both trans-tibial and trans-femoral amputation subjects, for a total duration of up to 5 sessions.
Initially, the fall detection algorithm will be evaluated on trans-femoral and trans-tibial amputees performing the test while wearing their prosthesis.
In a second step, the experimentally obtained prognostic markers of fall risk will be studied (i.e., using one or both of the perturbation platforms described below).
The markers thus obtained are to be validated by comparison with markers already established in clinical practice or in the literature.
Experimental platforms The platforms are composed of a mechanism to simulate and investigate the aid that the prosthetic system can provide in the event of a source of tripping and/or slipping.
- Conditions
- Lower Limb Amputation, Slip Perturbations, Fall Risk
- Being tested
- prosthetic group performs the entire protocol with their own prosthesis, Experimental Group
- Keywords
- amputation, stumble, slipping, lower limb, fall risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthetic group performs the entire protocol with their own prosthesisProcedure or surgery
The 1st session is the enrolment and functional evaluation one. The following 2 we test the algorithm functionality verification; one session for both platforms. The last 2 sessions are necessary to acquire prognostic markers for falls; one session for both platforms.
The balance disturbance tests will take place on two platforms:
- The sliding platform consists of a metal supporting structure and a wooden cover, which has a manual release mechanism that allows the activation of the tile responsible for simulating the events that occur during sliding.
- The stumbling platform consists of a metal supporting structure and a wooden cover, which features an electronically activated plastic and foam tripping mechanism that simulates the sequence of events that occur during a stumble.
Experimental GroupDevice
The fall detection algorithm will be evaluated first. In a second step, the experimentally obtained prognostic markers of fall risk will be studied. The markers thus obtained shall be validated by comparison with markers already established in clinical practice or in the literature.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with unilateral trans-femoral and/or trans-tibial amputation. | Not described Receives: Procedure: prosthetic group performs the entire protocol with their own prosthesis; Device: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
algorithm validation
Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers
Measured: baseline
Secondary outcomes (1)
data aquiring
Acquire data on amputees to be used for the development of a new version of the detection algorithm and its testing.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start6 Feb 2024
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
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 Lower Limb 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 8 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Biorobotic Institute Scuola Superiore sant'Anna Pisa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883942
- Sponsor's protocol ID
- MOTU++ Studio Clinico Pedane
- Acronym
- MOTU++ pedane
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang F, D'Andrea SE, Nunnery MJ, Kay SM, Huang H. Towards design of a stumble detection system for artificial legs. IEEE Trans Neural Syst Rehabil Eng. 2011 Oct;19(5):567-77. doi: 10.1109/TNSRE.2011.2161888. Epub 2011 Aug 18.
PubMed 21859635Palumbo P, Randi P, Moscato S, Davalli A, Chiari L. Degree of Safety Against Falls Provided by 4 Different Prosthetic Knee Types in People With Transfemoral Amputation: A Retrospective Observational Study. Phys Ther. 2022 Apr 1;102(4):pzab310. doi: 10.1093/ptj/pzab310.
PubMed 35079822Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk Factors for Falls in People With a Lower Limb Amputation: A Systematic Review. PM R. 2017 Feb;9(2):170-180.e1. doi: 10.1016/j.pmrj.2016.07.531. Epub 2016 Jul 30.
PubMed 27485674Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.
PubMed 11494181
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
- ClinicalTrials.gov ID
- NCT06883942
- Acronym / sponsor ID
- MOTU++ pedane / MOTU++ Studio Clinico Pedane
- Conditions
- Lower Limb Amputation, Slip Perturbations, Fall Risk
- Keywords
- amputation, stumble, slipping, lower limb, fall risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Biorobotic Institute Scuola Superiore sant'Anna Pisa
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 19 Mar 2025 (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 study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation
Detailed description
The protocol will involve both trans-tibial and trans-femoral amputation subjects, for a total duration of up to 5 sessions.
Initially, the fall detection algorithm will be evaluated on trans-femoral and trans-tibial amputees performing the test while wearing their prosthesis.
In a second step, the experimentally obtained prognostic markers of fall risk will be studied (i.e., using one or both of the perturbation platforms described below).
The markers thus obtained are to be validated by comparison with markers already established in clinical practice or in the literature.
Experimental platforms The platforms are composed of a mechanism to simulate and investigate the aid that the prosthetic system can provide in the event of a source of tripping and/or slipping.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with unilateral trans-femoral and/or trans-tibial amputation. | – | Procedure: prosthetic group performs the entire protocol with their own prosthesis, Device: Experimental Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with monolateral trans-femoral and/or trans-tibial.
Key inclusion criteria (4 listed)
- Trans-femoral or trans-tibial lower limb amputation;
- Functional medical classification: Level K3-K4;
- Subjects who have had a prosthesis for at least 1 year (experienced wearers);
- Informed consent signed by the subject
Key exclusion criteria (6 listed)
- Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits);
- Cardiac device wearers (PMK or AICD);
- Cognitive impairment (MMSE adjusted for age and schooling <24);
- Inability or unwillingness to provide informed consent;
- Severe depressive symptomatology - Beck Depression Inventory (BDI-II <19);
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 |
|---|---|---|
| prosthetic group performs the entire protocol with their own prosthesisThe 1st session is the enrolment and functional evaluation one. The following 2 we test the algorithm functionality verification; one session for both platforms. The last 2 sessions are necessary to acquire prognostic markers for falls; one session for both platforms. The balance disturbance tests will take place on two platforms: * The sliding platform consists of a metal supporting structure and a wooden cover, which has a manual release mechanism that allows the activation of the tile responsible for simulating the events that occur during sliding. * The stumbling platform consists of a metal supporting structure and a wooden cover, which features an electronically activated plastic and foam tripping mechanism that simulates the sequence of events that occur during a stumble. | Procedure or surgery | Subjects with unilateral trans-femoral and/or trans-tibial amputation. |
| Experimental GroupThe fall detection algorithm will be evaluated first. In a second step, the experimentally obtained prognostic markers of fall risk will be studied. The markers thus obtained shall be validated by comparison with markers already established in clinical practice or in the literature. | Device | Subjects with unilateral trans-femoral and/or trans-tibial amputation. |
Primary outcome
algorithm validation
Time frame: baseline
Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers
1 secondary outcome
data aquiring
Time frame: baseline
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 27 Mar 2026.
- Results publication: PubMed 21859635Zhang F, D'Andrea SE, Nunnery MJ, Kay SM, Huang H. Towards design of a stumble detection system for artificial legs. IEEE Trans Neural Syst Rehabil Eng. 2011 Oct;19(5):567-77. doi: 10.1109/TNSRE.2011.2161888. Epub 2011 Aug 18.
- Results publication: PubMed 35079822Palumbo P, Randi P, Moscato S, Davalli A, Chiari L. Degree of Safety Against Falls Provided by 4 Different Prosthetic Knee Types in People With Transfemoral Amputation: A Retrospective Observational Study. Phys Ther. 2022 Apr 1;102(4):pzab310. doi: 10.1093/ptj/pzab310.
- Results publication: PubMed 27485674Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk Factors for Falls in People With a Lower Limb Amputation: A Systematic Review. PM R. 2017 Feb;9(2):170-180.e1. doi: 10.1016/j.pmrj.2016.07.531. Epub 2016 Jul 30.
- Results publication: PubMed 11494181Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation and Slip Perturbations, 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 6 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 27 Mar 2026. 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?
algorithm validation (time frame: baseline). 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 NCT06883942, 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 27 Mar 2026.