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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03924310

Recruitment Status Not yet recruiting

First Posted April 23, 2019

Last update posted August 28, 2020

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.

  • Condition or Disease:Amputation; Traumatic, Hand
  • Intervention/Treatment: Device: FeetBack System Active
    Device: FeetBack System Passive
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 4 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
  • Masking: None (Open Label) ()
  • Primary Purpose: Device Feasibility
  • Official Title: Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
  • Estimated Study Start Date: September 2020
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Arm amputees
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
Commercially available hand prosthesis with feedback device turned on

Device: FeetBack System Passive
Commercially available hand prosthesis with feedback device turned off
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Time needed to finish tasks [ Time Frame: 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 Outcome Measures: 1. Design acceptance [ Time Frame: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Martin Berli, Dr. med. +41 44 386 57 58 martin.berli@balgrist.ch

Contact: Volker Koch, Prof. Dr. +41 32 321 63 84 volker.koch@bfh.ch

Locations

Switzerland
Balgrist University Hospital
Zurich

Sponsors and Collaborators

Martin Berli

Bern University of Applied Sciences

More Information
  • Responsible Party: Martin Berli
  • ClinicalTrials.gov Identifier: NCT03924310 History of Changes
  • Other Study ID Numbers: FeetBack
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: August 28, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Martin Berli: myoelectric prostheses
    closed-loop control
    vibrotactile feedback
    feedback display
  • Additional relevant MeSH terms: Amputation, Traumatic