Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment (FeetBack)
Primary Purpose
Amputation; Traumatic, Hand
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FeetBack System Active
FeetBack System Passive
Sponsored by
About this trial
This is an interventional device feasibility trial for Amputation; Traumatic, Hand focused on measuring myoelectric prostheses, closed-loop control, vibrotactile feedback, feedback display
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
Sites / Locations
- Balgrist University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm amputees
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03924310
First Posted
April 15, 2019
Last Updated
December 8, 2021
Sponsor
Martin Berli
Collaborators
Bern University of Applied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03924310
Brief Title
Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
Acronym
FeetBack
Official Title
Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
November 22, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Berli
Collaborators
Bern University of Applied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Hand
Keywords
myoelectric prostheses, closed-loop control, vibrotactile feedback, feedback display
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm amputees
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
FeetBack System Active
Intervention Description
Commercially available hand prosthesis with feedback device turned on
Intervention Type
Device
Intervention Name(s)
FeetBack System Passive
Intervention Description
Commercially available hand prosthesis with feedback device turned off
Primary Outcome Measure Information:
Title
Success rate
Description
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.
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Time needed to finish tasks
Description
Comparison of average time needed to finish a set of manipulation tasks, using a hand prosthesis with/without tactile feedback.
Time Frame
Through study completion, an average of 1 month
Other Pre-specified Outcome Measures:
Title
Design acceptance
Description
Design acceptance of the study devices by the subjects with a questionnaire (yes/no, scale, open questions) for further development
Time Frame
Up to 2 weeks after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Berli, Dr. med.
Organizational Affiliation
Universitätsklinik Balgrist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
36389246
Citation
Morand R, Brusa T, Schnuriger N, Catanzaro S, Berli M, Koch VM. FeetBack-Redirecting touch sensation from a prosthetic hand to the human foot. Front Neurosci. 2022 Oct 26;16:1019880. doi: 10.3389/fnins.2022.1019880. eCollection 2022.
Results Reference
derived
Learn more about this trial
Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
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