Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Enrolling

Conditions: Upper Limb Amputees

Treatments: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Electromyography recording with HD-sEMG

Study type: Interventional

Funder types: Other

Identifiers

NCT06486571

CP-PAS-01-23

528-2023 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

All participants

Experimental group

Treatment:

Other: Electromyography recording with HD-sEMG

Other: Transcutaneous Electrical Nerve Stimulation (TENS)