Skip to main content
Clinical Trials/NCT03924310
NCT03924310
Completed
N/A

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

Martin Berli1 site in 1 country4 target enrollmentAugust 9, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Amputation; Traumatic, Hand
Sponsor
Martin Berli
Enrollment
4
Locations
1
Primary Endpoint
Success rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2021
End Date
November 23, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Martin Berli
Responsible Party
Sponsor Investigator
Principal Investigator

Martin Berli

Representative of technical orthopedic department

Balgrist University Hospital

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

Outcomes

Primary Outcomes

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

  • Time needed to finish tasks(Through study completion, an average of 1 month)

Study Sites (1)

Loading locations...

Similar Trials