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

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic, Hand
• Intervention / Treatment: Device: FeetBack System Active; Device: FeetBack System Passive

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: FeetBack System Active; Commercially available hand prosthesis with feedback device turned on; Device: FeetBack System Passive; Commercially available hand prosthesis with feedback device turned off

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Success rate to detect the contact force levels to differentiate between different objects and to manipulate fragile objects, using a hand prosthesis with/without tactile feedback.	Through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed to finish tasks	Comparison of average time needed to finish a set of manipulation tasks, using a hand prosthesis with/without tactile feedback.	Through study completion, an average of 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Design acceptance	Design acceptance of the study devices by the subjects with a questionnaire (yes/no, scale, open questions) for further development	Up to 2 weeks after study completion

Collaborators and Investigators

• Sponsor: Martin Berli
• Collaborators: Bern University of Applied Sciences
• Investigators: Principal Investigator: Martin Berli, Dr. med., Universitätsklinik Balgrist

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): November 22, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: myoelectric prostheses; closed-loop control; vibrotactile feedback; feedback display
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: FeetBack

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No