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

Not Applicable

Completed

• Conditions: Amputation, Traumatic; Prosthesis User
• Interventions: Device: smartskin non-invasive sensory feedback

• Registration Number: NCT03876405
• Lead Sponsor: Lund University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• acquired forearm amputation

Exclusion Criteria

• psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sensory feedback	smartskin non-invasive sensory feedback	A non-invasive air-mediated sensory feedback system embedded in the prosthesis socket. Group description: Individuals with acquired forearm amputation.

Primary Outcome Measures

Name	Time	Method
Assessment of Myoelectric Control - ACMC	2 days	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.
Task performance questionnaire	2 days	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.
Pointing task	2 days	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.