Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses

Prosthesis User Clinical Trial

Official title:

Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses in Everyday Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876405
• Other study ID #: SFB2014
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.

Description:

A non invasive sensory feedback system in embedded in the prosthetic socket will be tested on forearm amputees in their everday life. Pretests and follow up will contain objective outcome assessments and semi-structured interviews.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acquired forearm amputation

Exclusion Criteria:

• psychiatric disorders

Related Conditions & MeSH terms

• Amputation, Traumatic
• Prosthesis User

Intervention

Device:
• smartskin non-invasive sensory feedback
The sensory feedback system used was a simple non-invasive, non-electronic system based on air-mediated pressure. A silicone glove with bulbs (35 mm in length) volar in every fingertip was made and applied on a VariPlus Speed hand (OttoBock), size 7¾. The sensory feedback system was embedded in the prosthetic socket.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Myoelectric Control - ACMC	An observational assessment where you rate the subjects' capacity of myoelectric control in a bimanual activity. The scoring was made by an experienced external rater.	2 days
Primary	Task performance questionnaire	21 questions about sensory feedback from the prosthesis, agency, body ownership, performance in activity and phantom limb pain. Self-administered estimation on a 7 grade Likert-scale.	2 days
Primary	Pointing task	A objective measurement of body ownership. The subject are asked to mark on a ruler, with the hand prosthesis hidden, where they estimate the location of the prosthetic index finger.	2 days