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

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

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Key information

Conditions

Amputation, Traumatic Prosthesis User Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

acquired forearm amputation

Exclusion criteria

psychiatric disorders

Treatment and study plan

smartskin non-invasive sensory feedback

Device

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.

Primary outcomes

Assessment of Myoelectric Control - ACMC

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Mar 15, 2019
Registry last updated: Mar 15, 2019

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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