StrokeNESTNCT07572487
User Requirements of the Neurorehabilitation Ecosystem for Sustained Therapy
An observational study of Stroke, run by Sint Maartenskliniek at 3 sites in 3 countries.
Trial summary
In this study the user requirements of the Neurorehabilitation Ecosystem for Sustained Treatment (NEST), a system containing: an exercise app, smartwatch and virtual coach designed for stroke survivors, will be investigated. Focus groups or interviews will be held in three countries, Italy, Spain and the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 40 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Jan 2022to 15 Aug 2022
- Phase
- Observational
- 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
Study population: All healthcare professionals worked at the participating centres. All stroke survivors received or were still receiving treatment at the participating centres. Most caregivers were related to the participating stroke survivors or recruited via social media.
Who may be able to join
- People who had a stroke and were discharged from the rehabilitation center within one year from now.
- Range of different hand functioning measured with the Fugl-Meyer Assessment (only the upper extremity part will be used)
- 18 years or older
- An informal caregiver of a stroke patient (mostly a family member or friend)
- Stroke patient was discharged within one year from now
- 18 years or older
- Working as a therapist in one of the centres
- Working with stroke patients on a daily basis
Who cannot join
- Low cognitive functioning, with a mini mental state examination score below 21
- Extremely limited smartphone user
- Patients suffering from aphasia
- Caregivers:
- Extremely limited smartphone user
- Healthcare professionals:
- Extremely limited smartphone user
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: User Requirements of the Neurorehabilitation Ecosystem for Sustained Therapy (NEST): an Integrated Home-based Rehabilitation Tool
In this study the user requirements of the Neurorehabilitation Ecosystem for Sustained Treatment (NEST), a system containing: an exercise app, smartwatch and virtual coach designed for stroke survivors, will be investigated. Focus groups or interviews will be held in three countries, Italy, Spain and the Netherlands. During these focus groups open-ended questions will be asked about the different components of NEST.
Read the detailed description
After stroke, patients often experience a reduced arm-function. This function can partly be regained during a long and intensive rehabilitation. However, due to the ageing population and the increasing stroke cases, there is not enough time and money for this long and intensive rehabilitation in a rehabilitation center. Home-based rehabilitation could offer a solution to this problem. Currently, a new home-based rehabilitation system is being developed, named the Neurorehabilitation Ecosystem for Sustained Treatment (NEST). This system consists of three different components: an app, in which games can be played; a smartwatch which monitor the arm function of the patient and a virtual coach which will motivate the patient. However, this system is still being developed and it is unknown whether it meets the user requirements.
Therefore, the goal of this study is to identify factors for NEST to maximize usability, acceptance and usefulness by stroke patients, therapists and caregivers in the home situation. We conducted a qualitative focus group study, with 5 patients, 5 caregivers and 5 therapists in each of the three centers in Italy, Spain and the Netherlands. In each of the three centers, 3 focus groups or interviews will take place; one with patients, one with caregivers and one with therapists. First an introduction will be given in which the participants will see a video of NEST. Then questions about the systems will be asked. In total this will take 2 hours with a 30-minute break for patients. The main objective of this study is to get a list with factors that NEST needs to fulfill in order for it to be used by patients, caregivers and therapists. This will come out of an inductive thematic analysis from the focus groups.
- Conditions
- Stroke
- Keywords
- focus group, interview, user requirements, home-based rehabilitation, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors | Stroke survivors with an affected upper limb function due to stroke | |
| Caregivers | Caregivers who support a stroke survivor in their close environment | |
| Healthcare professionals | Healthcare professionals with experience in working with stroke survivors on a daily basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inductive thematic analysis on user requirements gained during focus groups
Focus groups will be held. One with stroke survivors, one with caregivers and one with healthcare professionals. The researcher will be the leader.
Measured: 2 hours
Inductive thematic analysis on user requirements gained during interviews
Interviews between the researcher and either stroke survivors, caregivers or healthcare professionals.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start15 Jan 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT
- Responsible party
- Sponsor
- Investigators
- Noël Keijsers, Prof, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572487
- Sponsor's protocol ID
- 1027
- Acronym
- NEST
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the nature of the data (interviews and focus groups) it is not possible to provide complete anonymized data.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Requirements of the Neurorehabilitation Ecosystem for Sustained Therapy (NEST): an Integrated Home-based Rehabilitation Tool
- ClinicalTrials.gov ID
- NCT07572487
- Acronym / sponsor ID
- NEST / 1027
- Conditions
- Stroke
- Keywords
- focus group, interview, user requirements, home-based rehabilitation, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 7 May 2026 (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.
In this study the user requirements of the Neurorehabilitation Ecosystem for Sustained Treatment (NEST), a system containing: an exercise app, smartwatch and virtual coach designed for stroke survivors, will be investigated. Focus groups or interviews will be held in three countries, Italy, Spain and the Netherlands. During these focus groups open-ended questions will be asked about the different components of NEST.
Detailed description
After stroke, patients often experience a reduced arm-function. This function can partly be regained during a long and intensive rehabilitation. However, due to the ageing population and the increasing stroke cases, there is not enough time and money for this long and intensive rehabilitation in a rehabilitation center. Home-based rehabilitation could offer a solution to this problem. Currently, a new home-based rehabilitation system is being developed, named the Neurorehabilitation Ecosystem for Sustained Treatment (NEST). This system consists of three different components: an app, in which games can be played; a smartwatch which monitor the arm function of the patient and a virtual coach which will motivate the patient. However, this system is still being developed and it is unknown whether it meets the user requirements.
Therefore, the goal of this study is to identify factors for NEST to maximize usability, acceptance and usefulness by stroke patients, therapists and caregivers in the home situation. We conducted a qualitative focus group study, with 5 patients, 5 caregivers and 5 therapists in each of the three centers in Italy, Spain and the Netherlands. In each of the three centers, 3 focus groups or interviews will take place; one with patients, one with caregivers and one with therapists. First an introduction will be given in which the participants will see a video of NEST. Then questions about the systems will be asked. In total this will take 2 hours with a 30-minute break for patients. The main objective of this study is to get a list with factors that NEST needs to fulfill in order for it to be used by patients, caregivers and therapists. This will come out of an inductive thematic analysis from the focus groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors | – | –Stroke survivors with an affected upper limb function due to stroke |
| Caregivers | – | –Caregivers who support a stroke survivor in their close environment |
| Healthcare professionals | – | –Healthcare professionals with experience in working with stroke survivors on a daily basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All healthcare professionals worked at the participating centres. All stroke survivors received or were still receiving treatment at the participating centres. Most caregivers were related to the participating stroke survivors or recruited via social media.
Key inclusion criteria (8 listed)
- People who had a stroke and were discharged from the rehabilitation center within one year from now.
- Range of different hand functioning measured with the Fugl-Meyer Assessment (only the upper extremity part will be used)
- 18 years or older
- An informal caregiver of a stroke patient (mostly a family member or friend)
- Stroke patient was discharged within one year from now
Key exclusion criteria (7 listed)
- Low cognitive functioning, with a mini mental state examination score below 21
- Extremely limited smartphone user
- Patients suffering from aphasia
- Extremely limited smartphone user
- Extremely limited smartphone user
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inductive thematic analysis on user requirements gained during focus groups
Time frame: 2 hours
Focus groups will be held. One with stroke survivors, one with caregivers and one with healthcare professionals. The researcher will be the leader.
Inductive thematic analysis on user requirements gained during interviews
Time frame: 1 hour
Interviews between the researcher and either stroke survivors, caregivers or healthcare professionals.
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 7 May 2026.
- Individual participant dataSharing planned: No. Due to the nature of the data (interviews and focus groups) it is not possible to provide complete anonymized data.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Noël Keijsers, Prof principal investigator
Sint Maartenskliniek
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Sint Maartenskliniek at 3 sites in 3 countries.
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 8 inclusion and 7 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Netherlands, Spain. 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?
Inductive thematic analysis on user requirements gained during focus groups (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 7 May 2026.