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

Not Applicable

Completed

• Conditions: Amputation; Traumatic, Hand
• Interventions: Device: FeetBack System Active; Device: FeetBack System Passive

• Registration Number: NCT03924310
• Lead Sponsor: Martin Berli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-23
• Study Start: 2021-08-09
• Primary Completion: 2021-11-22
• Study Completion: 2021-11-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm amputees	FeetBack System Active	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.
Arm amputees	FeetBack System Passive	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.

Primary Outcome Measures

Name	Time	Method
Success rate	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

Name	Time	Method
Time needed to finish tasks	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.

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland