AmputationMOTU++NCT06616402
Assessing the Usability and Reliability of the Prototype Prosthesis Devices
A study testing prototype prosthetic group in people with Amputation and Traumatic Amputations, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amputation, Traumatic Amputations, Leg Amputation
- What is being tested?
- prototype prosthetic group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years;
- Lower limb amputation at the transfemoral or transtibial level;
- Functional medical classification: Level K3-K4 [25];
- Subjects wearing a prosthesis for at least 1 year (experienced wearers);
- Maximum body weight 100 kg.
Who cannot join
- Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
- Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
- Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
- Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
- Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
- Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MOTU++ - Studio Clinico Protesi
The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.
- Conditions
- Amputation, Traumatic Amputations, Leg Amputation
- Being tested
- prototype prosthetic group
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prototype prosthetic groupDevice
These 3 sessions will commence only upon successful completion of the prosthesis safety and reliability tests conducted in the preceding sessions.
For each module combination, a session will be conducted to assess motor performance through the acquisition of spatiotemporal parameters and energy efficiency parameters of gait. Motor performance will be evaluated using functional assessment tests and data will be recorded during the following activities:
- parallel bar walking on flat ground
- parallel bar walking on an inclined surface
- treadmill walking with a safety harness
- stair climbing/descending with a handrail
- standing up and sitting down from a chair within parallel bars At the end of each session, satisfaction questionnaires (ad hoc questionnaire) will be completed. At the end of the experiment, a usability scale for the devices (ad hoc System Usability Scale) will be completed.
Each session is expected to last approximately 2.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| prosthetic group performs the entire protocol with the prosthesis prototype. | Other | Not described Receives: Device: prototype prosthetic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: baseline
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 1
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 2
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 3
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 4
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 5
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Measured: day 6
Secondary outcomes (17)
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Measured: day 1
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Measured: day 2
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Measured: day 3
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Measured: day 4
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Measured: day 5
10mwt - 10 meters walking test
to evaluate walking capacity measured in seconds
Measured: baseline
10mwt - 10 meters walking test
to evaluate walking capacity measured in seconds
Measured: day 4
6mwt - 6 minutes walking test
to evaluate walking capacity measured in metres
Measured: baseline
System Usability Scale
a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with 0-100 that assesses the usability of the prosthesis.
Measured: day 6.
TUG - Time Up and Go
to assess lower limb capabilities in seconds
Measured: baseline
TUG - Time Up and Go
to assess lower limb capabilities in seconds
Measured: day 4
SCT - Stair Climbing Test
to assess the capabilities of climb 8 stairs in seconds
Measured: baseline
SCT - Stair Climbing Test
to assess the capabilities of climb 8 stairs in seconds
Measured: day 4
6mwt - 6 minutes walking test
to evaluate walking capacity measured in metres
Measured: day 6
FCT - Functional Reach Test
to assess the balance in centimeters
Measured: baseline
Functional Reach Test
to assess the balance in centimeters
Measured: day 5
Cost of Transport -COT
To assess metabolic consumption
Measured: day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Nov 2023
- Primary completion1 Oct 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616402
- Sponsor's protocol ID
- CP-PAI-02-23
- Acronym
- MOTU++
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- MOTU++ - Studio Clinico Protesi
- ClinicalTrials.gov ID
- NCT06616402
- Acronym / sponsor ID
- MOTU++ / CP-PAI-02-23
- Conditions
- Amputation, Traumatic Amputations, Leg Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Sep 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 aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prosthetic group performs the entire protocol with the prosthesis prototype. | Other | Device: prototype prosthetic group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years;
- Lower limb amputation at the transfemoral or transtibial level;
- Functional medical classification: Level K3-K4 [25];
- Subjects wearing a prosthesis for at least 1 year (experienced wearers);
- Maximum body weight 100 kg.
Key exclusion criteria (6 listed)
- Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
- Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
- Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
- Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
- Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
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 |
|---|---|---|
| prototype prosthetic groupThese 3 sessions will commence only upon successful completion of the prosthesis safety and reliability tests conducted in the preceding sessions. For each module combination, a session will be conducted to assess motor performance through the acquisition of spatiotemporal parameters and energy efficiency parameters of gait. Motor performance will be evaluated using functional assessment tests and data will be recorded during the following activities: * parallel bar walking on flat ground * parallel bar walking on an inclined surface * treadmill walking with a safety harness * stair climbing/descending with a handrail * standing up and sitting down from a chair within parallel bars At the end of each session, satisfaction questionnaires (ad hoc questionnaire) will be completed. At the end of the experiment, a usability scale for the devices (ad hoc System Usability Scale) will be completed. Each session is expected to last approximately 2.5 hours. | Device | prosthetic group performs the entire protocol with the prosthesis prototype. |
Primary outcome
Ad hoc check list for Adverse Event
Time frame: baseline
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Ad hoc check list for Adverse Event
Time frame: day 1
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Ad hoc check list for 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 for 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 for 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 for Adverse Event
Time frame: day 5
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Ad hoc check list for Adverse Event
Time frame: day 6
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
17 secondary outcomes
Borg Scale
Time frame: day 1
Borg Scale
Time frame: day 2
Borg Scale
Time frame: day 3
Borg Scale
Time frame: day 4
Borg Scale
Time frame: day 5
10mwt - 10 meters walking test
Time frame: baseline
10mwt - 10 meters walking test
Time frame: day 4
6mwt - 6 minutes walking test
Time frame: baseline
System Usability Scale
Time frame: day 6.
TUG - Time Up and Go
Time frame: baseline
TUG - Time Up and Go
Time frame: day 4
SCT - Stair Climbing Test
Time frame: baseline
SCT - Stair Climbing Test
Time frame: day 4
6mwt - 6 minutes walking test
Time frame: day 6
FCT - Functional Reach Test
Time frame: baseline
Functional Reach Test
Time frame: day 5
Cost of Transport -COT
Time frame: day 6
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.
- 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?
A study testing prototype prosthetic group in people with Amputation and Traumatic Amputations, 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 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?
Ad hoc check list for Adverse Event (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.