NCT03876405

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3.8 years

First QC Date

March 11, 2019

Last Update Submit

March 13, 2019

Conditions

Amputation, TraumaticProsthesis User

Keywords

hand prosthesissensory feedbackamputationupper limb

Outcome Measures

Primary Outcomes (3)

  • 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.

    2 days

  • 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.

    2 days

  • 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.

    2 days

Study Arms (1)

sensory feedback

EXPERIMENTAL

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

Device: smartskin non-invasive sensory feedback

Interventions

smartskin non-invasive sensory feedbackDEVICE

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.

sensory feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acquired forearm amputation

You may not qualify if:

  • psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32733187DERIVED

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 15, 2019

Study Start

April 1, 2015

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share