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

• ClinicalTrials.gov Identifier: NCT03924310
• Recruitment Status: Completed
• First Posted: April 23, 2019
• Last Update Posted: December 9, 2021
• Sponsor: Martin Berli
• Collaborator: Bern University of Applied Sciences
• Information provided by (Responsible Party): Martin Berli, Balgrist University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Amputation; Traumatic, Hand	Device: FeetBack System Active; Device: FeetBack System Passive	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
• Actual Study Start Date: August 9, 2021
• Actual Primary Completion Date: November 22, 2021
• Actual Study Completion Date: November 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Success rate [ Time Frame: Through study completion, an average of 1 month ]
   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.

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Design acceptance [ Time Frame: Up to 2 weeks after study completion ]
   Design acceptance of the study devices by the subjects with a questionnaire (yes/no, scale, open questions) for further development

Eligibility Criteria

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

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

Contacts and Locations

Locations

Switzerland

Balgrist University Hospital

Zurich, Switzerland, 8008

Sponsors and Collaborators

Martin Berli

Bern University of Applied Sciences

Investigators

• Principal Investigator: Martin Berli, Dr. med.; Universitätsklinik Balgrist

More Information

• Responsible Party: Martin Berli, Representative of technical orthopedic department, Balgrist University Hospital
• ClinicalTrials.gov Identifier: NCT03924310
• Other Study ID Numbers: FeetBack
• First Posted: April 23, 2019
• Last Update Posted: December 9, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin Berli, Balgrist University Hospital:

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

Additional relevant MeSH terms:

Amputation, Traumatic; Wounds and Injuries