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

Martin Berli

Status: Completed

Conditions: Amputation; Traumatic, Hand

Treatments: Device: FeetBack System Active; Device: FeetBack System Passive

Study type: Interventional

Funder types: Other

Identifiers

NCT03924310

FeetBack

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Arm amputees

Experimental group

Description:

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.

Treatment:

Device: FeetBack System Active

Device: FeetBack System Passive