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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Vrije Universiteit Brussel

    Jette, Brussels Capital, 1090

Other trials in Belgium

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.

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 groups in NCT04833088
Study groupRoleWhat they receive
Healthcare professionalsOtherNot described
Receives: Other: Focus group discussions
Patients who suffer from spatial neglectOtherNot described
Receives: Other: Focus group discussions
Patients who have walking difficultiesOtherNot described
Receives: Other: Focus group discussions
Patients who require long term use of an IV-standOtherNot described
Receives: Other: Focus group discussions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted6 Apr 2021
  2. Study start10 Jun 2021
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2022

Resources

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)
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

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.

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