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

NCT03924310 | Completed DMC

• 1 other identifier: FeetBack
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time needed to finish tasks

  Through study completion, an average of 1 month

Other Outcomes (1)

• Design acceptance

  Up to 2 weeks after study completion

Study Arms (1)

Arm amputees

EXPERIMENTAL

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; Device: FeetBack System Passive

Interventions

FeetBack System Active DEVICE

Commercially available hand prosthesis with feedback device turned on

Arm amputees

FeetBack System Passive DEVICE

Commercially available hand prosthesis with feedback device turned off

Arm amputees

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Berli: lead
• Bern University of Applied Sciences: collaborator

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36389246 DERIVED

Study Officials

• Martin Berli, Dr. med.

  Universitätsklinik Balgrist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Representative of technical orthopedic department

Model Details: The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 23, 2019
• Study Start: August 9, 2021
• Primary Completion: November 22, 2021
• Study Completion: November 23, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

CH (1)