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

Amputation; Traumatic, Hand Clinical Trial

— FeetBack  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924310
• Other study ID #: FeetBack
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: November 23, 2021

Study information

• Verified date: December 2021
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 23, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Hand

Intervention

Device:
• FeetBack System Active
Commercially available hand prosthesis with feedback device turned on
• FeetBack System Passive
Commercially available hand prosthesis with feedback device turned off

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Martin Berli	Bern University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Design acceptance	Design acceptance of the study devices by the subjects with a questionnaire (yes/no, scale, open questions) for further development	Up to 2 weeks after study completion
Primary	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	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