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
About this trial
This is an interventional other trial for Amputation, Traumatic focused on measuring hand prosthesis, sensory feedback, amputation, upper limb
Eligibility Criteria
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
NCT ID
NCT03876405
First Posted
March 11, 2019
Last Updated
March 13, 2019
Sponsor
Lund University Hospital
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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