Upper Limb AmputationNCT06886295
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
A study of Upper Limb Amputation, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.
Trial summary
The investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Limb Amputation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with transradial amputation, and minimum experience in the use of myoelectric prosthesis;
- subjects who have expressed informed consent to participate in the study and consent to data processing.
Who cannot join
- subjects with obvious visual and oculomotor defects;
- concomitant comorbidities/disabilities/chronic conditions, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), which may interfere with the performance of the study;
- pregnancy or breastfeeding;
- declared or evident cognitive deficits that compromise the understanding of the required tasks (mini Mental State Examination≤ 24);
- difficulty in understanding the Italian language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bo, 40136
Paolo Sassu, Medical Doctor, Surgeon, PhD, 0039 051 636 6111, paolo.sassu@ior.it
Paolo Sassu, Medical Director, Clinic IV
About this study
The investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. The prosthesis is composed at the minimum of skin-surface electrodes for myoelectric signals, vibrotactile actuators, a multi-articulated and instrumented hand prosthesis and a centralized control system. Such system is validated for several weeks in non-supervised environments.
Read the detailed description
The investigators propose a pilot single-center study, randomized with crossover design to compare the intuitive control strategy with the standard-in-care direct control strategy.
Primary Objectives The primary objective is to validate a non-invasive, transradial prosthesis that integrates the latest advancements for intuitive, bidirectional and multi-articulated control. This validation is intended to be conducted in unsupervised environments (i.e., home-use). The prosthesis under validation combines intuitive movement control through pattern recognition applied to myoelectric signals, and vibrotactile sensory feedback in response to touch and object release events.
The validation is conducted through well-established functional tests in the field designed to measure dexterity and motor coordination, and through data on daily usage.
Secondary Objectives The secondary objective is to validate the proposed prosthesis based on subjective assessments regarding user satisfaction, perceived capacity to control the device, and perceived level of disability.
Additionally, the study aims to assess whether participation in this research has any impact on the control of the clinically used prosthesis. To this end, both functional tests and self-assessment questionnaires will be used to evaluate the clinical prosthesis before and after the trial protocol.
- Conditions
- Upper Limb Amputation
- Being tested
- Prosthetic controller
- Keywords
- amputation, prosthesis, pattern recognition, regression, vibrotactile, sensory feedback, myoelectric, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic controllerDevice
The intervention includes an upper limb prosthesis composed at the minimum by skin-surface electrodes for myoelectric signals, a vibrotactile actuator, a multi-articulated and instrumented hand prosthesis and a centralized control system. The centralized prosthetic controller processes the myoelectric signals acquired at the residual limb to enable the movements on the multi-articulated prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| machine learning based prosthesis control | Experimental | A non-invasive upper limb prosthesis whose control is facilitated through machine learning applied to myoelectric signals. The movements on the prosthesis are triggered by intuitive muscular contractions performed at the residual limb. Receives: Device: Prosthetic controller |
| conventional direct control | Active comparator | A non-invasive upper limb prosthesis whose control is enable by standard-in-care movement control strategy. The movements on the prosthesis are sequentially triggered through simple thresholds applied to myoelectric signals. Receives: Device: Prosthetic controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Southampton Hand Assessment Procedure (SHAP)
The test consists of sequentially manipulating 6 lightweight and 6 heavyweight abstract objects and 14 activities of daily living over a specific formboard. Lightweight objects should be manipulated first. The task involves pushing a button to start a timer, picking up and moving the object from the rear slot to the front slot on the board, and completing the task by depressing the button on the timer again.
Measured: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
Clothespin Relocation Test (CRT)
The objective is to evaluate the performance of a prosthetic user in a controlled environment and subsequently provide a measure of the user's expected functionality level outside the laboratory/clinic. The user is instructed to allocate three clothespins between a horizontal rod and a vertical rod and asked to fill out a post-test survey after five trials of the CRT.
Measured: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
Pick and Lift Test (PLT)
The PLT measures motor coordination, i.e., the ability to coordinate the grip force and the load force while lifting an object, as well as the reliability of the recorded control signal while transporting the object. While the subject is sitting on a chair with the intact arm parallel to the trunk, and the amputated limb extending anteriorly on a table, he/she is asked to lift a small object from the table with the prosthesis.
Measured: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
Virtual Egg Test (VET)
The VET resembles the task of transporting fragile and robust objects, thus requiring both gross and fine dexterity. The test is composed of 11 Virtual Eggs that collapse if the grasping force exceeds their breaking thresholds, ranging from 0.4 N to 11.5 N. The test aims to transport each Virtual Egg over the barrier in the centre of the test platform without breaking it and as fast as possible. The metrics measured during the test are combined and provide two indexes that evaluate, respectively, gross and fine dexterity.
Measured: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
Usage of the prosthesis
The prosthesis, for as long as it is powered, will log real-time information about its usage during the day. Such data will allow us to calculate the total wear/use time, as well as the quality of the usage (which moments are used and how often). The data should also provide basic information for debugging in case of system failures and adverse events.
Measured: Usage data will be recorded by the prosthesis during the two 4 weeks home-trials
Secondary outcomes (6)
NASA-TLX questionnaire
The NASA-TLX is a questionnaire to assess subjective workload, in terms of mental, physical, temporal, performance, effort and frustration. The resulting score ranges from 0 to 100, where 0 means no workload (very easy) and 100 means maximum workload (extremely demanding).
Measured: Administered after each functional test (primary outcomes). Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again at the end of the study
abilHAND-ULA
The abilHAND-ULA is a questionnaire for self-assessing the perceived manual ability for individuals with upper limb amputation. The cumulative score ranges from 0 to 66, with higher scores indicating better manual ability.
Measured: Administered before, after and at each week of the two home-trials
OPUS-UEFS
The Orthotics and Prosthetics User's Survey - Upper Extremity Functional Scale for Prosthesis Users (OPUS-UEFS) is a self-report measure designed to assess the functional status of individuals using upper limb prostheses, considering the level of amputation and prosthesis type. Each of the 23 items is rated on a 5-point scale (0 = cannot do this activity, 5 = very easy). The cumulative score ranges from 0 to 92, with higher scores indicating greater functional ability.
Measured: Administered before, after and at each week of the two home-trials
TAPES
The Trinity Amputation and Prosthesis Experience Scales (TAPES) is a self-administered questionnaire that comprises psychosocial adjustment, activity restriction, and prosthetic satisfaction domains, each with 3 subscales. Each subscale is scored individually, with higher scores consistently indicating more positive outcomes. Summing scores across different subscales is not appropriate.
Measured: Administered before, after and at each week of the two home-trials
QuickDASH
The Disability of the Arm, Shoulder and Hand is a self-administered questionnaire aimed at evaluating upper limb function. It is a 30-item questionnaire (main section) where each item is rated from 1 to 5 for increased difficulty/severity. The overall score ranges from 0 to 100.
Measured: Administered before, after and at each week of the two home-trials
SUS
The System Usability Scale (SUS) is a ten-item attitude Likert scale giving a global view of subjective assessment of usability. Users respond to 10 statements, rating them from 1 (Strongly Disagree) to 5 (Strongly Agree). The higher the score, the higher the perceived usability. Usually a score of 68 is the average industrial benchmark, and a score >80 is considered as excellent.
Measured: Administered before, after and at each week of the two home-trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators propose a pilot single-center study, randomized with crossover design to compare the intuitive control strategy with the standard-in-care direct control strategy. Each condition will be assessed with a 4 weeks home-trial, separated by at least 1 wash-out week. Each condition will dispose of a non-invasive upper limb prosthesis composed at the minimum of skin-surface electrodes for myoelectric signals, a multi-articulated and instrumented hand prosthesis, a vibrotactile actuator enabled at touch/release of the objects, and a centralized control system. The two conditions will differ based on the movement control strategy, machine learning based as opposed to conventional threshold control. The former tries to simplify the control of all degrees of freedom available by decoding intuitive muscular contraction at the residual limb. The latter applies simple thresholds to the myoelectric signals to provide sequential activations of all degrees of freedom available.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Istituto Ortopedico Rizzoli di Bologna
- Responsible party
- Principal investigator, Christian Cipriani, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886295
- Sponsor's protocol ID
- IOR2024FIT4
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
- ClinicalTrials.gov ID
- NCT06886295
- Acronym / sponsor ID
- IOR2024FIT4
- Conditions
- Upper Limb Amputation
- Keywords
- amputation, prosthesis, pattern recognition, regression, vibrotactile, sensory feedback, myoelectric, EMG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'AnnaUniversity, hospital or other
- Collaborators
- IRCCS Istituto Ortopedico Rizzoli di Bologna
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 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 investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. The prosthesis is composed at the minimum of skin-surface electrodes for myoelectric signals, vibrotactile actuators, a multi-articulated and instrumented hand prosthesis and a centralized control system. Such system is validated for several weeks in non-supervised environments.
Detailed description
The investigators propose a pilot single-center study, randomized with crossover design to compare the intuitive control strategy with the standard-in-care direct control strategy.
Primary Objectives The primary objective is to validate a non-invasive, transradial prosthesis that integrates the latest advancements for intuitive, bidirectional and multi-articulated control. This validation is intended to be conducted in unsupervised environments (i.e., home-use). The prosthesis under validation combines intuitive movement control through pattern recognition applied to myoelectric signals, and vibrotactile sensory feedback in response to touch and object release events.
The validation is conducted through well-established functional tests in the field designed to measure dexterity and motor coordination, and through data on daily usage.
Secondary Objectives The secondary objective is to validate the proposed prosthesis based on subjective assessments regarding user satisfaction, perceived capacity to control the device, and perceived level of disability.
Additionally, the study aims to assess whether participation in this research has any impact on the control of the clinically used prosthesis. To this end, both functional tests and self-assessment questionnaires will be used to evaluate the clinical prosthesis before and after the trial protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators propose a pilot single-center study, randomized with crossover design to compare the intuitive control strategy with the standard-in-care direct control strategy. Each condition will be assessed with a 4 weeks home-trial, separated by at least 1 wash-out week. Each condition will dispose of a non-invasive upper limb prosthesis composed at the minimum of skin-surface electrodes for myoelectric signals, a multi-articulated and instrumented hand prosthesis, a vibrotactile actuator enabled at touch/release of the objects, and a centralized control system. The two conditions will differ based on the movement control strategy, machine learning based as opposed to conventional threshold control. The former tries to simplify the control of all degrees of freedom available by decoding intuitive muscular contraction at the residual limb. The latter applies simple thresholds to the myoelectric signals to provide sequential activations of all degrees of freedom available.
| Arm | Type | Receives |
|---|---|---|
| machine learning based prosthesis control | Experimental | Device: Prosthetic controllerA non-invasive upper limb prosthesis whose control is facilitated through machine learning applied to myoelectric signals. The movements on the prosthesis are triggered by intuitive muscular contractions performed at the residual limb. |
| conventional direct control | Active comparator | Device: Prosthetic controllerA non-invasive upper limb prosthesis whose control is enable by standard-in-care movement control strategy. The movements on the prosthesis are sequentially triggered through simple thresholds applied to myoelectric signals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects with transradial amputation, and minimum experience in the use of myoelectric prosthesis;
- subjects who have expressed informed consent to participate in the study and consent to data processing.
Key exclusion criteria (5 listed)
- subjects with obvious visual and oculomotor defects;
- concomitant comorbidities/disabilities/chronic conditions, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), which may interfere with the performance of the study;
- pregnancy or breastfeeding;
- declared or evident cognitive deficits that compromise the understanding of the required tasks (mini Mental State Examination≤ 24);
- difficulty in understanding the Italian language.
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 controllerThe intervention includes an upper limb prosthesis composed at the minimum by skin-surface electrodes for myoelectric signals, a vibrotactile actuator, a multi-articulated and instrumented hand prosthesis and a centralized control system. The centralized prosthetic controller processes the myoelectric signals acquired at the residual limb to enable the movements on the multi-articulated prosthesis. | Device | conventional direct control, machine learning based prosthesis control |
Primary outcome
Southampton Hand Assessment Procedure (SHAP)
Time frame: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
The test consists of sequentially manipulating 6 lightweight and 6 heavyweight abstract objects and 14 activities of daily living over a specific formboard. Lightweight objects should be manipulated first. The task involves pushing a button to start a timer, picking up and moving the object from the rear slot to the front slot on the board, and completing the task by depressing the button on the timer again.
Clothespin Relocation Test (CRT)
Time frame: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
The objective is to evaluate the performance of a prosthetic user in a controlled environment and subsequently provide a measure of the user's expected functionality level outside the laboratory/clinic. The user is instructed to allocate three clothespins between a horizontal rod and a vertical rod and asked to fill out a post-test survey after five trials of the CRT.
Pick and Lift Test (PLT)
Time frame: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
The PLT measures motor coordination, i.e., the ability to coordinate the grip force and the load force while lifting an object, as well as the reliability of the recorded control signal while transporting the object. While the subject is sitting on a chair with the intact arm parallel to the trunk, and the amputated limb extending anteriorly on a table, he/she is asked to lift a small object from the table with the prosthesis.
Virtual Egg Test (VET)
Time frame: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial
The VET resembles the task of transporting fragile and robust objects, thus requiring both gross and fine dexterity. The test is composed of 11 Virtual Eggs that collapse if the grasping force exceeds their breaking thresholds, ranging from 0.4 N to 11.5 N. The test aims to transport each Virtual Egg over the barrier in the centre of the test platform without breaking it and as fast as possible. The metrics measured during the test are combined and provide two indexes that evaluate, respectively, gross and fine dexterity.
Usage of the prosthesis
Time frame: Usage data will be recorded by the prosthesis during the two 4 weeks home-trials
The prosthesis, for as long as it is powered, will log real-time information about its usage during the day. Such data will allow us to calculate the total wear/use time, as well as the quality of the usage (which moments are used and how often). The data should also provide basic information for debugging in case of system failures and adverse events.
6 secondary outcomes
NASA-TLX questionnaire
Time frame: Administered after each functional test (primary outcomes). Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again at the end of the study
abilHAND-ULA
Time frame: Administered before, after and at each week of the two home-trials
OPUS-UEFS
Time frame: Administered before, after and at each week of the two home-trials
TAPES
Time frame: Administered before, after and at each week of the two home-trials
QuickDASH
Time frame: Administered before, after and at each week of the two home-trials
SUS
Time frame: Administered before, after and at each week of the two home-trials
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Upper Limb Amputation, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna 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 2 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enzo Mastinu, MSc, BSc, PhD (0039 050 883111, enzo.mastinu@santannapisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Southampton Hand Assessment Procedure (SHAP) (time frame: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial). 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?
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 3 Apr 2025.