Amputation; Traumatic, HandFeetBackNCT03924310
Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
A study testing FeetBack System Active and FeetBack System Passive in people with Amputation; Traumatic, Hand, run by Martin Berli at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Amputation; Traumatic, Hand
- What is being tested?
- FeetBack System Active and FeetBack System Passive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Aug 2021to 23 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Amputation; Traumatic, Hand
- Being tested
- FeetBack System Active, FeetBack System Passive
- Keywords
- myoelectric prostheses, closed-loop control, vibrotactile feedback, feedback display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeetBack System ActiveDevice
Commercially available hand prosthesis with feedback device turned on
FeetBack System PassiveDevice
Commercially available hand prosthesis with feedback device turned off
| Study group | Role | What they receive |
|---|---|---|
| Arm amputees | Experimental | 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. Receives: Device: FeetBack System Active; Device: FeetBack System Passive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start9 Aug 2021
- Primary completion22 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation; Traumatic, HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Berli
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor-investigator, Martin Berli, Balgrist University Hospital
- Investigators
- Martin Berli, Dr. med., Principal investigator, Universitätsklinik Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924310
- Sponsor's protocol ID
- FeetBack
- Acronym
- FeetBack
- Status last verified
- Dec 2021
- First submitted
- 15 Apr 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36389246
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
- ClinicalTrials.gov ID
- NCT03924310
- Acronym / sponsor ID
- FeetBack / FeetBack
- Conditions
- Amputation; Traumatic, Hand
- Keywords
- myoelectric prostheses, closed-loop control, vibrotactile feedback, feedback display
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Martin BerliUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
| Arm | Type | Receives |
|---|---|---|
| Arm amputees | Experimental | Device: FeetBack System Active, Device: FeetBack System PassiveThis 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeetBack System ActiveCommercially available hand prosthesis with feedback device turned on | Device | Arm amputees |
| FeetBack System PassiveCommercially available hand prosthesis with feedback device turned off | Device | Arm amputees |
Primary outcome
Success rate
Time frame: 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.
1 secondary outcome
Time needed to finish tasks
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 36389246Morand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Berli, Dr. med. principal investigator
Universitätsklinik Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeetBack System Active and FeetBack System Passive in people with Amputation; Traumatic, Hand, run by Martin Berli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.