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

NCT ID: NCT03876405

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2019-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Amputation, Traumatic Prosthesis User

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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sensory feedback

A non-invasive air-mediated sensory feedback system embedded in the prosthesis socket.

Group description: Individuals with acquired forearm amputation.

Group Type EXPERIMENTAL

smartskin non-invasive sensory feedback

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* acquired forearm amputation

Exclusion Criteria

* psychiatric disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulrika Wijk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Wijk U, Carlsson IK, Antfolk C, Bjorkman A, Rosen B. Sensory Feedback in Hand Prostheses: A Prospective Study of Everyday Use. Front Neurosci. 2020 Jul 7;14:663. doi: 10.3389/fnins.2020.00663. eCollection 2020.

Reference Type DERIVED
PMID: 32733187 (View on PubMed)

Other Identifiers

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SFB2014

Identifier Type: -

Identifier Source: org_study_id

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