Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment

NCT ID: NCT03924310

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2021-11-23

Brief Summary

State-of-the-art myoelectric prostheses provide upper limb amputees with a remarkable variety of grip patterns but lack proper feedback from touch sensation. This restriction limits the controllability of multi-articulated robotic hands, resulting in the rejection of the device in many cases.

Amputees have often reminiscing sensations in the stump, i.e. by touching certain regions, it feels as if no longer existing fingers were touched. These regions form a phantom map and show promising results for touch feedback. However, not every amputee has one and the socket of a prosthesis offers limited space for additional devices. Thus, the investigators developed a feedback display which is worn in the shoe instead of the prosthesis itself. The investigators want to assess the viability of vibrotactile feedback stimulus on the foot as a substitution for pressure on the fingers of an artificial hand in a clinical study. The efforts are based on the hypothesis that a hand prosthesis with tactile feedback has better performance in manipulating fragile and heavy objects, compared with a standard commercial hand prosthesis without tactile feedback.

Conditions

Amputation; Traumatic, Hand

Keywords

myoelectric prostheses; closed-loop control; vibrotactile feedback; feedback display

Study Design

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

Study Groups

Arm amputees

This single arm conducts all experiments. In three out of four experiments both interventions (with feedback \& without feedback) are used, the fourth experiment does not allow the intervention without feedback.

Group Type: EXPERIMENTAL

FeetBack System Active

Intervention Type: DEVICE

Commercially available hand prosthesis with feedback device turned on

FeetBack System Passive

Intervention Type: DEVICE

Commercially available hand prosthesis with feedback device turned off

Interventions

FeetBack System Active

Commercially available hand prosthesis with feedback device turned on

Intervention Type: DEVICE

FeetBack System Passive

Commercially available hand prosthesis with feedback device turned off

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Sign the consent form
• Have basic knowledge of and trust in modern technologies
• Understand the experimental procedures and are willing to participate in the study
• Unilateral below- or above-elbow amputee
• Familiar with the usage of a myoelectric prosthesis

Exclusion Criteria

• Any form of skin disease
• Contraindication in the device, e.g. hypersensitivity or allergy against materials used in the device
• Impaired condition
• Known or suspected abuse of alcohol or drugs
• Unable to follow the instructions given during the experiments
• Participation at another clinical study with drugs or devices within 30 days before the study at hand
• Homeless person
• Enrollment of the Head of Studies, his/her family members, employees or other dependent persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bern University of Applied Sciences

OTHER

Sponsor Role: collaborator

Martin Berli

OTHER

Sponsor Role: lead

Responsible Party

Martin Berli

Representative of technical orthopedic department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Berli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Balgrist

Locations

Balgrist University Hospital

Zurich, , Switzerland

Countries

Switzerland

References

Morand R, Brusa T, Schnuriger N, Catanzaro S, Berli M, Koch VM. FeetBack-Redirecting touch sensation from a prosthetic hand to the human foot. Front Neurosci. 2022 Oct 26;16:1019880. doi: 10.3389/fnins.2022.1019880. eCollection 2022.

Reference Type: DERIVED

PMID: 36389246 (View on PubMed)

Other Identifiers

FeetBack

Identifier Type: -

Identifier Source: org_study_id