NCT03924310: FeetBack

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

Completed NA Last updated 9 December 2021

What this trial tests

NA trial testing FeetBack System Active in Amputation; Traumatic, Hand in 4 participants. Completed in 23 November 2021.

Timeline

9 August 2021

Primary endpoint
22 November 2021

23 November 2021

Quick facts

Lead sponsor	Martin Berli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	4
Start date	9 August 2021
Primary completion	22 November 2021
Estimated completion	23 November 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• FeetBack System Active
• FeetBack System Passive

Conditions studied

• Amputation; Traumatic, Hand — all drugs for Amputation; Traumatic, Hand →

Sponsor

Martin Berli

Who can join

Adults 18 to 55, any sex, with Amputation; Traumatic, Hand. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. FeetBack-Redirecting touch sensation from a prosthetic hand to the human foot.
   Morand R, Brusa T, Schnüriger N, Catanzaro S, et al · · 2022 · PMID 36389246 · DOI 10.3389/fnins.2022.1019880