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OpenTrials
Completed

NCT Number: NCT03924310

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

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.

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Key information

Conditions

Amputation; Traumatic, Hand

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeetBack System Active

Device

Commercially available hand prosthesis with feedback device turned on

FeetBack System Passive

Device

Commercially available hand prosthesis with feedback device turned off

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Martin Berli

Other

Collaborators

  • Bern University of Applied Sciences

Registry information

Acronym: FeetBack

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2019
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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