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

NCT ID: NCT06486571

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2026-04-22

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.

Conditions

Upper Limb Amputees

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

All participants

Group Type: EXPERIMENTAL

Electromyography recording with HD-sEMG

Intervention Type: OTHER

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)

Intervention Type: 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.

Interventions

Electromyography recording with HD-sEMG

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Protesi Inail

Budrio, BO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Emanuele Gruppioni, PhD

Role: CONTACT

e.gruppioni@inail.it

+390516936609

Facility Contacts

Emanuele Gruppioni, PhD

Role: primary

e.gruppioni@inail.it

+390516936609

Role: backup

e.gruppioni@inail.it

Other Identifiers

528-2023

Identifier Type: OTHER

Identifier Source: secondary_id

CP-PAS-01-23

Identifier Type: -

Identifier Source: org_study_id