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

NCT06486571 | Recruiting DMC

• 2 other identifiers: CP-PAS-01-23528-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Upper limb amputation; HD-sEMG; Pattern recognition; Sensory feedback; TENS

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  through study completion, an average of 2 year through study completion, an average of 2 year

• Development of encoding strategies

  through study completion, an average of 2 year through study completion, an average of 2 year

Study Arms (1)

All participants

EXPERIMENTAL

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

Interventions

Electromyography recording with HD-sEMG 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.

All participants

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.

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead

Study Sites (1)

Centro Protesi Inail

Budrio, BO, 40054, Italy

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Emanuele Gruppioni, PhD

CONTACT

+390516936609; e.gruppioni@inail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: April 23, 2024
• Primary Completion: December 22, 2025
• Study Completion: April 22, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)