Amputation; Traumatic, Hand
Conditions
Keywords
myoelectric prostheses, closed-loop control, vibrotactile feedback, feedback display
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.
Interventions
DEVICEFeetBack System Active
Commercially available hand prosthesis with feedback device turned on
DEVICEFeetBack System Passive
Commercially available hand prosthesis with feedback device turned off
Sponsors
Bern University of Applied Sciences
Martin Berli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Design acceptance | Up to 2 weeks after study completion | Design acceptance of the study devices by the subjects with a questionnaire (yes/no, scale, open questions) for further development |
Countries
Switzerland
Outcome results
None listed