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Clinical Trials/NCT06486571
NCT06486571
Recruiting
N/A

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

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro1 site in 1 country30 target enrollmentApril 23, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Upper Limb Amputees
Sponsor
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Enrollment
30
Locations
1
Primary Endpoint
Elicit somatic sensations in amputees
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2024
End Date
April 22, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Responsible Party
Sponsor

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);

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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 Sites (1)

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