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

• Sponsor: Lund University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03876405
• Collaborator: (none)
• Enrollment: 7
• Arm: 1
• Actual Duration (Months): 46

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amputation, Traumatic; Prosthesis User	Device: smartskin non-invasive sensory feedback	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses in Everyday Life.
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sensory feedback 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; 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.

Outcome Measures

Primary Outcome Measures

1. Assessment of Myoelectric Control - ACMC [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.

2. Task performance questionnaire [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.

3. Pointing task [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• acquired forearm amputation

Exclusion Criteria:

• psychiatric disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lund University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ulrika Wijk, Principal Investigator, Lund University Hospital
• ClinicalTrials.gov Identifier: NCT03876405
• Other Study ID Numbers: SFB2014
• First Posted: Mar 15, 2019
• Last Update Posted: Mar 15, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ulrika Wijk, Principal Investigator, Lund University Hospital: hand prosthesis; sensory feedback; amputation; upper limb
• Additional relevant MeSH terms: Amputation, Traumatic

Study Results

No Results Posted as of Mar 15, 2019