StrokeNCT04833088
Exploratory Study About the Implementation of Technology in the Rehabilitation
A study testing Focus group discussions in people with Stroke and Parkinson Disease, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Parkinson Disease, Covid19
- What is being tested?
- Focus group discussions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jun 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult (≥ 18 years)
- diagnosed with stroke (as defined by the World Health Organization) and suffering from spatial neglect
- able to verbally answer questions
- ability to give informed consent
- adult (≥ 18 years)
- suffering from gait problems (e.g. frail elderly, Parkinson Disease, recovering from COVID-19)
Show all 12Show fewer
- able to verbally answer questions
- ability to give informed consent
- adult (≥ 18 years)
- requires intensive use of an IV-stand during hospitalisation
- able to verbally answer questions
- ability to give informed consent
Who cannot join
- severe cognitive disability (based on assessment of the healthcare professionals)
- severe cognitive disability (based on assessment of the healthcare professionals)
- severe cognitive disability (based on assessment of the healthcare professionals)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Stroke, Parkinson Disease, Covid19, Neglect, Hemispatial
- Being tested
- Focus group discussions
- Medical subject headings
- Stroke, Parkinson Disease, COVID-19, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group discussionsOther
Focus group discussions will be organized to investigate the needs and requirements of the participants in terms of three pre-defined user scenarios.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare professionals | Other | Not described Receives: Other: Focus group discussions |
| Patients who suffer from spatial neglect | Other | Not described Receives: Other: Focus group discussions |
| Patients who have walking difficulties | Other | Not described Receives: Other: Focus group discussions |
| Patients who require long term use of an IV-stand | Other | Not described Receives: Other: Focus group discussions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overview of needs and requirements for the development of the three predefined user scenarios
Recurring themes in the transcribed data of the focus groups will be identified and checked for relevance in terms of the research question (e.g. key functionalities of the device, aesthetic requirements, ...). These relevant themes will then be combined to create an overview for every user scenario individually.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start10 Jun 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, AZ Sint Maria Halle, Odisee University college for applied sciences, Erasmus University Rotterdam, Jessa Hospital, Rehabilitation hospital Inkendaal, Rehabilitation hopsital Revarte
- Responsible party
- Sponsor
- Investigators
- Eva Swinnen, Prof. Ph.D, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833088
- Sponsor's protocol ID
- SAIRE FOCUSGR
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study About the Implementation of Technology in the Rehabilitation
- ClinicalTrials.gov ID
- NCT04833088
- Acronym / sponsor ID
- SAIRE FOCUSGR
- Conditions
- Stroke, Parkinson Disease, Covid19, Neglect, Hemispatial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, AZ Sint Maria Halle, Odisee University college for applied sciences, Erasmus University Rotterdam, Jessa Hospital, Rehabilitation hospital Inkendaal, Rehabilitation hopsital Revarte
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthcare professionals | Other | Other: Focus group discussions |
| Patients who suffer from spatial neglect | Other | Other: Focus group discussions |
| Patients who have walking difficulties | Other | Other: Focus group discussions |
| Patients who require long term use of an IV-stand | Other | Other: Focus group discussions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- adult (≥ 18 years)
- diagnosed with stroke (as defined by the World Health Organization) and suffering from spatial neglect
- able to verbally answer questions
- ability to give informed consent
- adult (≥ 18 years)
Key exclusion criteria (3 listed)
- severe cognitive disability (based on assessment of the healthcare professionals)
- severe cognitive disability (based on assessment of the healthcare professionals)
- severe cognitive disability (based on assessment of the healthcare professionals)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group discussionsFocus group discussions will be organized to investigate the needs and requirements of the participants in terms of three pre-defined user scenarios. | Other | Healthcare professionals, Patients who have walking difficulties, Patients who require long term use of an IV-stand, Patients who suffer from spatial neglect |
Primary outcome
Overview of needs and requirements for the development of the three predefined user scenarios
Time frame: through study completion, an average of 1 year
Recurring themes in the transcribed data of the focus groups will be identified and checked for relevance in terms of the research question (e.g. key functionalities of the device, aesthetic requirements, ...). These relevant themes will then be combined to create an overview for every user scenario individually.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Swinnen, Prof. Ph.D principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus group discussions in people with Stroke and Parkinson Disease, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overview of needs and requirements for the development of the three predefined user scenarios (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.