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

Study Overview
=================
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.

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

Conditions
-----------------
Amputation; Traumatic, Hand

Intervention / Treatment
-----------------
* Device: FeetBack System Active
* Device: FeetBack System Passive


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm amputees<br>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<br>* Commercially available hand prosthesis with feedback device turned on<br>Device: FeetBack System Passive<br>* Commercially available hand prosthesis with feedback device turned off<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to finish tasks | Comparison of average time needed to finish a set of manipulation tasks, using a hand prosthesis with/without tactile feedback. | Through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myoelectric prostheses, closed-loop control, vibrotactile feedback, feedback display