Clinical trial NCT03924310: Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
Official title: Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation; Traumatic, Hand
Keywords: myoelectric prostheses
closed-loop control
vibrotactile feedback
feedback display
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Bern University of Applied Sciences
First posted: 2019-04-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Success rate
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Time needed to finish tasks
timeFrame: Through study completion, an average of 1 month
Other outcomes:
measure: Design acceptance
timeFrame: Up to 2 weeks after study completion
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Universitätsklinik Balgrist
name: Martin Berli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.