Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04833088 |
| Other study ID # |
SAIRE FOCUSGR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2021 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Vrije Universiteit Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This qualitative study aims to identify the needs and recommendations of both patients and
healthcare professionals in terms of rehabilitation technology, more specific three
pre-defined user scenarios. These scenario were developed based on brainstorm sessions with
healthcare professionals from the rehabilitation ward of UZ Brussel and AZ Sint-Maria Halle.
The purpose of this study is to create an overview of recommendations that will be used to
develop the smart devices in a later stage of the SAIRE project.
Description:
STUDY DESIGN Based on the aforementioned user scenarios, an explorative qualitive study will
be conducted investigating the recommendations and requirements of both patients and
healthcare professionals in the development of the smart devices. Focus groups will be
organized at UZ Brussel and AZ Sint Maria Halle to collect data from the participants. These
discussions will be organized until data saturation is reached. Based on expectations, the
investigators estimate on average 3 focus groups for every user scenario will be needed. The
recommendations proposed in these focus group discussions will be analyzed and tested in the
lab to determine what smart devices are eligible for rehabilitation. The data will also be
used to develop AI algorithms that will be implemented in the smart devices.
USER SCENARIOS The first scenario focuses on the registration and triggering of movement of
the upper limb in patients with spatial neglect. The aim is to develop a low-budget smart
device that stimulates and analyzes movement of the affected side and gives feedback when
needed.
The second user scenario aims to combine different smart devices and AI algorithms to create
a mobile device that can be placed on a walking aid. This smart device will give feedback in
terms of stride length and cadence through visual and auditive cues. A combination of sensor
analysis and computer vision will monitor the gait pattern of the patient and correct where
needed. These sensors will also incorporate a fall detection system that sends out a signal
when a fall is detected.
The third and final scenario describes a smart intravenous (IV) pole that monitors the
location of the patient relative to the IV pole and automatically follows the patient during
walking. This device consists of a tracker and an accelerometer placed on the patient, and a
motorized IV pole that follows the patient and avoid obstacles through computer vision.
Additionally, a fall detection system will be integrated to monitor falls.
PROCEDURE Firstly, with regard to the Sars-COV-2 pandemic, all obligated prevention measure
will be followed when conducting the focus group discussion. All participants and researchers
will wear face masks, maintain distance (1.5 meters) and frequently disinfect hands using
alcohol-based hand sanitizer. Additionally, an adequate ventilation of the room will be
maintained. If necessary, the focus group discussions will be organized online, using
Microsoft Teams (Microsoft, USA).
Before the start of the focus groups, all participants will be asked to complete a form
focusing on sociodemographic characteristics (age, gender, occupation, …). After this form is
collected, the focus group starts.
Each focus group discussion will be led by one moderator and one assistant.The moderator
directs the discussion and ensures that all participants are involved. The observer on the
other hand takes notes of the conversation with a focus on verbal and non-verbal signs,
seating of the participants and unexpected interruptions. Additionally, the observer also
watches the time limit of approximately one hour (with regard to limited concentration
duration) and ensures no key issues are overlooked. All focus groups will be recorded, after
obtaining ethical approval of the participants. As mentioned before, data-collection will be
completed after data saturation is reached, and no new data is gathered from the
participants.
The focus group discussions start with an introduction in which the moderator presents him or
herself and the observer, and explains the purpose of the study. Secondly, the participants
are asked to shortly introduce themselves and describe any previous experience with smart
devices or technology in their rehabilitation plan (what was good, what could have been
better, …). Thirdly, a short presentation is given that creates a global picture of the user
scenarios. Finally, the discussion between the participants and the moderator is started
following a question guide. If necessary, side questions are used to refocus the conversation
and avoid off-topic discussions.
ANALYSIS Firstly, a descriptive analysis will be done for the sociodemographic
characteristics of the participants based on the completed forms, using SPSS 27 (IBM, USA).
Secondly, the data from the focus group discussion will be analyzed. The recorded focus
groups will be transcribed verbatim using Word (Microsoft, USA). A thematic content analysis
will be performed by the researchers using NVivo (QRS International, USA). For this analysis
the six steps of Braun and Clarke (2006) will be followed. Firstly, the researchers will
familiarize themselves with the data through repeated reading of the data. Secondly, the
initial codes will be generated as the researchers begin to take notes on relevant data
items. Once the entire data set is coded, the researcher will start collating the data in
preparation of the third step. For this next step, the researchers will scan the collated
data and take note of all themes that are potentially of relevance to form a thematic map.
The forth step in the thematic analysis involves reviewing the themes. This review will be
done both within each theme, as between different themes. All codes within a theme will be
checked to ensure a proper fit within the theme, and all individual themes will be assessed
in relation to the entire data set, to see whether the thematic map accurately represents the
data. In the fifth step, the researchers will define each theme. Additionally, for each
theme, the importance to the broader study topic will be described. Lastly, the final
analysis will be written based on all previous steps. The researchers will first analyze the
data separately. Afterwards, both researchers will compare their analysis and adjust until
agreement is reached. Data will be stored on a secure and locked server of the
Erasmushogeschool Brussel and will be kept five years after final publication of the study
results.
