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

Primary Purpose

Amputation, Traumatic, Prosthesis User

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
smartskin non-invasive sensory feedback
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Amputation, Traumatic focused on measuring hand prosthesis, sensory feedback, amputation, upper limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acquired forearm amputation

Exclusion Criteria:

  • psychiatric disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    sensory feedback

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 11, 2019
    Last Updated
    March 13, 2019
    Sponsor
    Lund University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03876405
    Brief Title
    Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses
    Official Title
    Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses in Everyday Life.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    January 31, 2019 (Actual)
    Study Completion Date
    January 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lund University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amputation, Traumatic, Prosthesis User
    Keywords
    hand prosthesis, sensory feedback, amputation, upper limb

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sensory feedback
    Arm Type
    Experimental
    Arm Description
    A non-invasive air-mediated sensory feedback system embedded in the prosthesis socket. Group description: Individuals with acquired forearm amputation.
    Intervention Type
    Device
    Intervention Name(s)
    smartskin non-invasive sensory feedback
    Intervention Description
    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 Outcome Measure Information:
    Title
    Assessment of Myoelectric Control - ACMC
    Description
    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.
    Time Frame
    2 days
    Title
    Task performance questionnaire
    Description
    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.
    Time Frame
    2 days
    Title
    Pointing task
    Description
    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.
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acquired forearm amputation Exclusion Criteria: psychiatric disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32733187
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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