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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03876405
Enrollment
7
Registered
2019-03-15
Start date
2015-04-01
Completion date
2019-01-31
Last updated
2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Traumatic, Prosthesis User

Keywords

hand prosthesis, sensory feedback, amputation, upper limb

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.

Interventions

DEVICEsmartskin 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.

Sponsors

Lund University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* acquired forearm amputation

Exclusion criteria

* psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Myoelectric Control - ACMC2 daysAn 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 questionnaire2 days21 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 task2 daysA 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026