Upper Limb AmputeesNCT06486571
Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS
A study testing Electromyography recording with HD-sEMG and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Upper Limb Amputees, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
Trial summary
Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Limb Amputees
- What is being tested?
- Electromyography recording with HD-sEMG and Transcutaneous Electrical Nerve Stimulation (TENS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2024to 22 Apr 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper limb amputation;
- Stable clinical condition;
- Skin integrity of the stump;
- Age between 18 and 65 years;
- High level of motivation to participate in the study and acceptance of the purpose of the study;
- Signed informed consent document.
Who cannot join
- Clinical instability;
- Dehiscence of the amputation wound;
- Failure to complete the informed consent;
- State of pregnancy;
- Implanted devices that can interfere with TENS stimulation (e.g. pacemakers);
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Protesi Inail
Budrio, BO, 40054
Emanuele Gruppioni, PhD, +390516936609, e.gruppioni@inail.it
e.gruppioni@inail.it
About this study
Official title: Development of Innovative Strategies for the Control of Robotic Hand Prostheses Based on High-density Electromyography and Restitution of Sensory Feedback Via Trans-cutaneous Electrical Stimulation
Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.
- Conditions
- Upper Limb Amputees
- Being tested
- Electromyography recording with HD-sEMG, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Upper limb amputation, HD-sEMG, Pattern recognition, Sensory feedback, TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography recording with HD-sEMGOther
Measurement of muscle electrical signal with HD-sEMG sensors, training of a pattern recognition classifier for hand gesture recognition, verification and comparison with state of the art.
Transcutaneous Electrical Nerve Stimulation (TENS)Other
Application of TENS by means of non-invasive superifical electrodes on the stump skin of the participants to restore multimodal somatotopical sensations of mechanoception, nociception and thermoception.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Not described Receives: Other: Electromyography recording with HD-sEMG; Other: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve gestures decoding by means of HD-sEMG decoding algorithms
The performance of HD-sEMG classifiers with variable number of classes will be evaluated in the offline phase in terms of accuracy of classification and F1-Score.
Measured: through study completion, an average of 2 year through study completion, an average of 2 year
Elicit somatic sensations in amputees
The performance of the stimulation strategy will be evaluated in terms of stimulus discrimination accuracy, a parameter that identifies the number of times the subject correctly reports the type of sensation elicited by the experimenter compared to the total number of stimulations performed.
Measured: through study completion, an average of 2 year through study completion, an average of 2 year
Secondary outcomes (2)
Increase the number of hand grasps to be classfiied
To explore the possibility of increasing the number of gestures that can be classified by the developed classification system, compared to the number of gestures that can be reproduced by prosthetic control solutions traditional and to evaluate the intuitiveness in using classifiers to control a polyarticulated prosthesis.
Measured: through study completion, an average of 2 year through study completion, an average of 2 year
Development of encoding strategies
Develop new algorithms for decoding motor intention from the myoelectric signal and new encoding algorithms for the sensory restitution by non-invasive stimulation and to evaluate the intuitiveness of the developed strategies.
Measured: through study completion, an average of 2 year through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start23 Apr 2024
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Apr 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 AmputeesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486571
- Sponsor's protocol ID
- CP-PAS-01-23
- Other IDs
- 528-2023
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Innovative Strategies for the Control of Robotic Hand Prostheses Based on High-density Electromyography and Restitution of Sensory Feedback Via Trans-cutaneous Electrical Stimulation
- ClinicalTrials.gov ID
- NCT06486571
- Acronym / sponsor ID
- CP-PAS-01-23
- Conditions
- Upper Limb Amputees
- Keywords
- Upper limb amputation, HD-sEMG, Pattern recognition, Sensory feedback, TENS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Apr 2026 (estimated)
- First posted
- 3 Jul 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.
Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Electromyography recording with HD-sEMG, Other: Transcutaneous Electrical Nerve Stimulation (TENS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Upper limb amputation;
- Stable clinical condition;
- Skin integrity of the stump;
- Age between 18 and 65 years;
- High level of motivation to participate in the study and acceptance of the purpose of the study;
Key exclusion criteria (5 listed)
- Clinical instability;
- Dehiscence of the amputation wound;
- Failure to complete the informed consent;
- State of pregnancy;
- Implanted devices that can interfere with TENS stimulation (e.g. pacemakers);
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 |
|---|---|---|
| Electromyography recording with HD-sEMGMeasurement of muscle electrical signal with HD-sEMG sensors, training of a pattern recognition classifier for hand gesture recognition, verification and comparison with state of the art. | Other | All participants |
| Transcutaneous Electrical Nerve Stimulation (TENS)Application of TENS by means of non-invasive superifical electrodes on the stump skin of the participants to restore multimodal somatotopical sensations of mechanoception, nociception and thermoception. | Other | All participants |
Primary outcome
Improve gestures decoding by means of HD-sEMG decoding algorithms
Time frame: through study completion, an average of 2 year through study completion, an average of 2 year
The performance of HD-sEMG classifiers with variable number of classes will be evaluated in the offline phase in terms of accuracy of classification and F1-Score.
Elicit somatic sensations in amputees
Time frame: through study completion, an average of 2 year through study completion, an average of 2 year
The performance of the stimulation strategy will be evaluated in terms of stimulus discrimination accuracy, a parameter that identifies the number of times the subject correctly reports the type of sensation elicited by the experimenter compared to the total number of stimulations performed.
2 secondary outcomes
Increase the number of hand grasps to be classfiied
Time frame: through study completion, an average of 2 year through study completion, an average of 2 year
Development of encoding strategies
Time frame: through study completion, an average of 2 year through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography recording with HD-sEMG and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Upper Limb Amputees, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro 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 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Gruppioni, PhD (+390516936609, e.gruppioni@inail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve gestures decoding by means of HD-sEMG decoding algorithms (time frame: through study completion, an average of 2 year through study completion, an average of 2 year). The study lists 2 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 Jul 2024.