Mobility Limitation Clinical Trial
Official title:
Usability and Acceptance of Exergames Among Elderly People and Physiotherapists - a Mixed Method Approach
This study is a usability design with qualitative and quantitative aspects. In one part,
with patients, physical strain and designs facets will be investigated and in another part
with physiotherapists, the therapeutic relevance and design features will be explored.
For this reasons 13-15 elderly people have to play an exergame, during their game playing
process, different measurements will be done. Additional 13-15 physiotherapists will also
playing the exergame, they will be asked about their opinions about the game.
Introduction:
The goal of a usability evaluation is to assess the degree to which a system is effective,
efficient and favours positive attitudes and responses from the intended users. Exergames in
particular present unique usability challenges. Because games are fundamentally different
than general productivity tools, traditional usability instruments valid for productivity
applications may fall short when used for serious games.
Additionally, serious games target audiences may not play games regularly; usability issues
alone can hinder the game play process negatively affecting the learning experience. For
this reason, user-based evaluation for exergames with adequate test user group is very
important to ensure that heterogeneous population will be able to interact easily with
innovative applications.
Exergames:
Exergames are defined as: ''Any number of types of video games that require the game player
to physically move in order to play''.
The important aspect, in comparison to a normal videogame, is that the player uses full body
movements to control on-screen action and is required to expend a significantly greater
amount of energy compared with resting levels.
One of the areas that have received attention of video game researchers is that of
therapeutic sessions. When exergames were used with elderly people for therapeutic sessions,
it showed that special needs have to be considered.
The GameUp project:
For this reason the project GameUp was started. On their Website the project consortium
state: "We will use IT technologies to promote mobility by encouraging elderly persons to be
more physical active and motivating them to move more by increasing their self-efficacy". In
this context exergames for elderly people were designed for Kinect® for windows. Kinect®
observes all the body movements from the game player, so that they can operate the game with
their body movements. In this context the game player is forced to move his body frequently
in a way that increases his agility.
Therapist's view:
How do physiotherapists view the arrival of exergames in therapy rehabilitation setting,
especially exergames for elderly people? Studies that focus on the therapist's view are
really rare. One reference came to the conclusion that: "Video games should not be seen as a
replacement of a therapist. The presence of the therapist will always be necessary for these
patients to ensure that they play the game in the correct seating position, to provide
mental support and social interaction during game play." But how do therapists view the use
from exergames which patients could do by themselves as self-training during rehabilitation
or at home? The same reference argues: "The therapist is paramount in introducing games or
virtual rehabilitation to end-users; if he will not adopt the tool in his practice, neither
will the patients."
Purpose of the Study:
The aim of this study is to evaluate, if elderly people accept exergames as self-training
method and if this exergame is user-friendly for elderly people and physiotherapists. An
additionally goal is to examine how physiotherapists evaluate the therapeutic benefit from
this exergame.
Research Question:
Are exergames useable and accepted for self-training for elderly people, by themselves as
well as by physiotherapists?
Design of the user trial:
This study is a usability design with qualitative and quantitative aspects. In one part,
with patients, physical strain and designs facets will be investigated and in another part
with physiotherapists, the therapeutic relevance and design features will be explored.
Ideally the attributes required to make the product usable should be specified and measured
quantitatively against predefined goals.
Number of users needed:
How many users are needed for a usability study is a controversial subject in the
literature. One main point is that: "The test users should ideally reflect the serious
game's target audience in terms of age, gender, education and any other demographic
characteristics". In an other study is mentioned two other important aspects: It seems that
serious usability problems were only found with the 13th and 15th participant. Furthermore
for a usability test, it is the aim to find a study design that uncovers usability problems
at the lowest cost.
In consideration of these arguments this study protocol will include 13-15 participants with
different mobility levels. As the mobility level is the most important demographic
character, it should be reflected by the user group.
For the physiotherapist the most important demographic character is their experience with
exergames, so for this reason 13-15 physiotherapists with different experiences with
exergames will be tested.
Measurements:
Heart Rate (HR):
Heart rate is an indicator of cardiovascular strain and provides an objective measure of
physical work load. HR of the elderly user will be measured before playing the game,
directly after finishing the game and after two minutes break.
The predefined usability criterion is: The mean HR of 80% of elderly users will be below 110
beats per minute. Previous studies have specified that heart rate between 90 and 110
indicates moderate cardiovascular strain.
Rate of Perceived Exertion (RPE):
Borg's RPE-Scale is a standardized, reliable and valid tool to describe the perception of
exertion. Elderly users will be presented the Borg's 15-graded RPE scale immediately after
completion of the task and will be asked to rate their perceived exertion.
The predefined usability criterion is: The RPE-score of 80% of elderly users will be below
14. This is based on previous studies where scores of more than 13 RPE have been associated
with an increased relative risk for musculoskeletal symptoms.
Body Part Discomfort Scale (BPD Scale):
The Body Part Discomfort Scale has become a standard discomfort assessment tool in
ergonomics research. Elderly users will be presented with a body map at the beginning and
immediately after completion of the user trial.
The predefined usability criterion is: BPD Scale reports of 80% of the elderly users will be
below 4. This is based on previous studies where moderate discomfort levels for any body
part were selected as a threshold where redesign should be considered.
Task Analysis:
The Perceive, Recall Plan and Perform System (PRPP) is a process-oriented assessment that
employs task analysis methods to determine problems with task performance. For this
usability study a task analysis will be done during an elderly user or a physiotherapist is
playing the game. The major task steps will be analysed to identify where the users
struggles with the game design.
The predefined usability criterion for elderly user is: 80% of the elderly users can perform
60% of the needed steps without assistance.
The predefined usability criterion for the physiotherapists is: 80% of the physiotherapist
can perform 80% of the needed steps without assistance.
User Questionnaire:
Furthermore to the objective measurements the users will be asked questions about their
feelings and opinions about the game. Especially the physiotherapists will be asked if they
see a positive therapeutic aspect and if they could imagine giving patients exergames as
self-training exercises. This will be done with a questionnaire that includes open questions
and five-point Likert scale questions. This is based on publications where it is considered
important that the user has a positive attitude towards the product, to ensure regular and
widespread use.
Data analyses:
Quantitative data will be collected to review the predefined usability criteria as specified
above, using simple descriptive statistics. As sampling will be selective rather than random
and the sample size will be small, statistical calculations will most likely be restricted
to using median values and ranges. The median is used when no normal distribution of the
data is expected and is considered a more robust value since it is not influenced by
extremes.
Qualitative data will be presented as a written summary of the open questions from the
questionnaires.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06396247 -
Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05975476 -
Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments
|
N/A | |
Completed |
NCT01647802 -
Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer
|
N/A | |
Completed |
NCT01614392 -
Lower Extremity Muscle and Function in the Elderly: Study 2
|
N/A | |
Enrolling by invitation |
NCT05736484 -
Randomized Clinical Trial to Improve Mobility After Hospitalization
|
N/A | |
Active, not recruiting |
NCT05678985 -
Evaluating Impact and Implementation of Choose to Move (Phase 4)
|
N/A | |
Completed |
NCT06025656 -
Assessment of the Reliability and Validity of the Leg Lateral Reach Test in Adolescent Tennis Players
|
N/A | |
Completed |
NCT04760392 -
Goal-directed Mobilization of Medical Inpatients
|
N/A | |
Enrolling by invitation |
NCT06434298 -
Provincial Scale-up of Choose to Move (CTM) Phase 4
|
N/A | |
Recruiting |
NCT05516030 -
HIFT for People With Mobility-Related Disabilities
|
N/A | |
Not yet recruiting |
NCT06264362 -
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
|
N/A | |
Withdrawn |
NCT04044846 -
Promoting Movement in Older Adults in the Community
|
N/A | |
Terminated |
NCT03558841 -
Effect of Lyra Gait Training on the Mobility of Geriatric Rehabilitation Inpatients
|
N/A | |
Not yet recruiting |
NCT03675490 -
ABLE (Arts-Based Exercise Enhancing LongEvity)
|
N/A | |
Completed |
NCT02913976 -
Changes on Pain and Range of Motion by the Use of Kinesio Taping in Patients Diagnosed With Cervical Pain
|
N/A | |
Completed |
NCT02913963 -
Changes on Pain and Range of Motion by the Use of Kinesio Taping in Subjects With Myofascial Trigger Point
|
N/A | |
Completed |
NCT05081856 -
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
|
N/A | |
Withdrawn |
NCT02298374 -
Evaluation of Homecare Reablement, the Trondheim Model
|
N/A | |
Completed |
NCT02498704 -
Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain
|
N/A | |
Completed |
NCT00177359 -
Restoring Skill in Walking
|
Phase 2 |