Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS
- Conditions
- Upper Limb Amputees
- Interventions
- Other: Electromyography recording with HD-sEMGOther: Transcutaneous Electrical Nerve Stimulation (TENS)
- Registration Number
- NCT06486571
- Lead Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All participants Transcutaneous Electrical Nerve Stimulation (TENS) - All participants Electromyography recording with HD-sEMG -
- Primary Outcome Measures
Name Time Method Elicit somatic sensations in amputees 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.
Improve gestures decoding by means of HD-sEMG decoding algorithms 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.
- Secondary Outcome Measures
Name Time Method Increase the number of hand grasps to be classfiied through study completion, an average of 2 year through study completion, an average of 2 year 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.
Development of encoding strategies through study completion, an average of 2 year through study completion, an average of 2 year 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.
Trial Locations
- Locations (1)
Centro Protesi Inail
🇮🇹Budrio, BO, Italy