To investigate if patients with a variety of hand and wrist problems can conduct measurements, using a mobile application integrated with the Manus VR glove and a digital dynamometer, as an alternative for conventional measurements conducted by a…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Accuracy of range of motion is defined as the agreement between the ManusVR
glove and the conventional goniometer, consisting of three repetitions per
measuring method.
- Reliability of range of motion, measured with the ManusVR glove, is defined
as the consistency of the measure with repeated observations. (time interval of
2 weeks)
- Feasibility of range of motion is defined as the percentage completely
conducted measurements of all conducted measurements using the ManusVR glove
- Accuracy of grip/pinch strength is defined as the agreement between the
digital dynamometer and a conventional dynamometer, consisting of three
repetitions per measuring method.
- Reliability of grip/pinch strenght, measured with the digital dynamometer, is
defined as the consistency of the measure with repeated observations. (time
interval of 2 weeks)
- Feasibility of grip/pinch strength is defined as the percentage completely
conducted measurements of all conducted measurements using the digital
dynamometer.
- duration of measurement in minutes.
Secondary outcome
geen
Background summary
In Holland, the incidence of hand and wrist problems is 12.5% of people aged 25
years or older. Hand and wrist diseases can have a great implication on the
quality of life when not treated properly.1,2 Common hand and wrist problems
include fractures, arthrosis and Dupuytren*s disease. During treatment,
objective and consequent measurements of the hand function are important to
evaluate progression and change treatment course if necessary. Examination of
hand function consists of measuring joint range of motion (with a goniometer) ,
grip and pinch strength (with a dynamometer) and patient reported outcome
measures (PROM*s). However, assessment of hand function is time consuming and
inaccurate. Therefore, physicians often partially carry out or even totally
skip these measurements during follow-up visits. Resulting in poor insights in
treatment progression for physician and patient. Patients measuring hand
function using a mobile application, integrated with a digital measuring glove
and digital dynamometer, could result in more accurate and consequent
measurements. This could prevent unnecessary operations and costly
rehabilitation therapies. Thereby, physicians can spent more time conversating
with their patient during visits.
Technical specifications
The Manus VR glove is a digital device that measures hand and wrist position
and range of motion using a variety of sensors. The glove is made of
antibacterial polyester and weighs only 65 grams. Therefore it is no burden to
wear for patients. The Manus VR glove is currently used in the prototyping
industry and for gaming.
The mobile application will be developed by Synappz, a medical application
developer who is certified in secure data storage. Clinical outcomes will be
visable for physicians and patients in the application.
Study objective
To investigate if patients with a variety of hand and wrist problems can
conduct measurements, using a mobile application integrated with the Manus VR
glove and a digital dynamometer, as an alternative for conventional
measurements conducted by a physician.
Study design
Prospective observational research
Study burden and risks
The burden experienced regarding time spent will most likely not exceed 20
minutes per visit. Approximately 10 minutes will be spent measuring patients
using the conventional method (goniometer and dynamometer) and 10 minutes will
be spent measuring with the Manus VR. These measurements are done every
follow-up visit. On average a patient has 4 follow-up visits, which would cost
the patient 80 minutes of extra time spend in the hospital when participating
in this study.
Using the Manus VR glove to measure hundreds of patients could risk the
transmission of micro-organism from patient to patients. Although, the glove is
made of anti-bacterial polyester and even if bacteria are transmitted, the
chance that patients will experience any physical discomfort by this is
neglectable. However, we will use disposable latex gloves (if not allergic) to
wear underneath the Manus VR glove to meet regular hygiene protocols.
Subjects could experience mild discomfort during physical examination and
testing, but this will be no different from physical examination during routine
follow-up. The Manus VR glove weighs only 65 grams, which does not influence
hand movement. No serious events are expected to occur due to measuring with
the Manus VR glove. Reduction of risks will be done according to inclusion and
exclusion criteria. If complications arise, the treating physician will
proportionate the adequate treatment according to the current protocols of
treatment based on the published literature.
Nicolaas Maesstraat 91-2
Amsterdam 1071PT
NL
Nicolaas Maesstraat 91-2
Amsterdam 1071PT
NL
Listed location countries
Age
Inclusion criteria
New patients of 18 years and older who present on the outpatient clinical of
the traumatology or plastic surgery with either: 1. fracture of the hand or
wrist, 2. artrosis of the hand or wrist, and 3. Dupuytren's disease.
Exclusion criteria
Non Dutch speaker
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69489.100.19 |