StrokePHRASE-2023NCT06374927
Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study
An observational study of Stroke, run by Donders Centre for Neuroscience at 4 sites in 3 countries.
Trial summary
The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge. The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation Gaming System (VR-based mobile application)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 25 Apr 2024to 30 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients at different time points after stroke (acute, subacute, and chronic).
Who may be able to join
- Patients presenting an ischemic or intracerebral haemorrhagic stroke
- Age > 18 years old
- Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC≥2).
- Lesion localisation by clinical symptoms/signs.
- Able to sit on a chair or a wheelchair to interact with the RGS system.
- Minimal experience with smartphone technology based on the clinician's opinion
- Willing to participate and agree to comply with the trial scheme and procedures
- Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study.
Who cannot join
- Presence of a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
- Severe cognitive capabilities that prevent the execution of the experiment, either evaluated by the MoCA < 19 or based on the clinician's opinion.
- Arteriovenous malformation or lesions not related to a stroke.
- Severe associated impairments such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia, or apraxia), major pain, or other neuromuscular impairments.
- Pre-stroke history of upper limb motor disability.
- Unable to use the RGS independently according to the clinician's observations and lacking support from a caregiver to use the RGS.
- Refusal to sign the consent form.
- No experience with smartphone technology or based on the clinician's opinion.
Trial locations and contacts
4 sites in 3 countries.
Anna Mura contact
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Parc Sanitari Sant Joan de Déu
Barcelona
Raffaele Fiorillo, Dr., raffaele.fiorillo@sjd.es
Raffaele Fiorillo
- Not yet recruiting
IRF La Salle
Madrid
Miguel Gómez Martínez, Dr., miguel.gomez@lasallecampus.es
Miguel Gómez Martínez, Dr.
France1 site, 1 recruiting
- Not yet recruiting
Centre hospitalier universitaire de Limoges
Limoges, 87000
Stephane Mandigout, Dr., stephane.mandigout@unilim.fr
Romania1 site, 1 recruiting
- Not yet recruiting
Cluj Rehabilitation Hospital
Cluj-Napoca, Cluj, 400066
Stefan Strilciuc, PhD., stefan.strilciuc@genomics-center.ro
About this study
The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge.
The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge.
Read more
Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientific principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home.
There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales.
The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience.
The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke.
Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks.
Read the detailed description
The rapid growth in the number of stroke patients needing care and rehabilitation requires an urgent scientifically grounded, and scalable response. There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. The PHRASE project combines theoretical neuroscience, and intervention protocols based on VR AR technology, the RGS, making it an excellent alternative to solving cognitive training.
The study is a feasibility study based on both quantitative and qualitative data collection. The general objective is to measure the usability of the system, including the user experience, adherence, and acceptance of the PHRASE system.
Specifically, the patient interacts with the RGSapp, a mobile app system that through the mobile registers the patient's movements and performance during the tasks to evaluate, reassess and update training protocols through AI-based algorithms. The clinicians have access to MIMS (Medical Information Management System) a portal that allows them to manage the patient profiles and deliver precise and objective metrics of the performance of the patient together with dashboards for therapists and clinicians. It facilitates diagnostics, monitoring, intervention scheduling, data storage and analytics, and reports and patient management.
The primary objective of this study is to measure the usability, adherence, user experience and acceptance of the PHRASE system during a six-week intervention.
Secondary outcome parameters will be assessed with clinical scales to explore the effectiveness of performing motor and cognitive assessments online and cognitive treatments provided through the RGSapp technology.
Investigators hypothesize that the personalized training supported by the PHRASE system is:
- Highly accepted by patients and clinicians. More specifically, it is expected that this approach to show good user experience and usability by the patients and ease patients' management by the clinicians.
- It increases the frequency and time spent with the rehabilitation program. More specifically, it is expected this approach shows good adherence to treatment.
- Explore the impact of the PHRASE system on cognitive assessment, function impairment, and quality of life.
STUDY DESIGN AND POPULATION: The study is a feasibility study based on both quantitative and qualitative data collection. The general objective is to measure the usability of the system, the user experience, the adherence, and the acceptance of the PHRASE system. Each clinical site will include 30-50 stroke patients (in any stroke stage), minimum age of 18 years. Over six weeks, the participants will integrate the PHRASE system into their daily routines, running parallel to their regular neurorehabilitation treatment.
STUDY SETTING: The study will be conducted in parallel in different European hospitals. The experimentation involves 3 different phases: Baseline assessment (T0) before the start of the trial, remote assessment (T1) and Final evaluation (T2) at the end of the trial, after 6 weeks.
- Conditions
- Stroke
- Being tested
- Rehabilitation Gaming System (VR-based mobile application)
- Keywords
- Stroke, Rehabilitation, Virtual Reality (VR), Augmented Reality (AR)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Gaming System (VR-based mobile application)Device
The study intervention includes using the mobile phone technology RGSapp. This application integrates sensor data for delivering patient-tailored VR and AR-based training via gamified exercises for cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. Receives: Device: Rehabilitation Gaming System (VR-based mobile application) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Usability will be assessed at T2 by the System Usability Scale (SUS): The System Usability Scale is a reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, from 'Strongly agree' to 'Strongly disagree'.
Measured: Week 6
User experience
User experience will be assessed at T2 by the User Experience Questionnaire (UEQ): the scales of the questionnaire cover a comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience aspects (originality, stimulation) are measured.
Measured: Week 6
Adherence
Adherence will be assessed by the total time the RGSapp is used, in comparison to the advised RGSapp sessions for the entire duration of the study. Via the user ID, it is possible to monitor the patient's access to the RGSapp and the hours trained.
Measured: Week 6
Acceptance
Acceptance will be assessed at T2 by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): the instrument is a self-administered questionnaire assessing user satisfaction with assistive technology products and associated services.
Measured: Week 6
Secondary outcomes (8)
The Montreal Cognitive Assessment (MoCA)
MoCA is a cognitive test validated as a highly sensitive tool for early detection of mild cognitive impairment (MCI). MoCA accurately and quickly assess the following: short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation to time and place.
Measured: Baseline, Week 6
Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE)
It is a stroke-specific and performance-based impairment index. It is designed to assess motor functioning, sensation, balance, and joint range of motion and joint pain in patients with post-stroke hemiplegia.
Measured: Baseline, Week 6
Hamilton Depression Rating Scale (HDRS)
It is an instrument used for assessing symptoms of depression. It has been used in many key studies of depression and its treatment. The instrument is designed to be administered by clinicians after a structured or unstructured interview of the patient to determine their symptoms.
Measured: Baseline, Week 6
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a nine-item unidimensional questionnaire designed to measure fatigue in people with chronic diseases. The scale is a self-report, paper-and-pencil requiring 2-3 min to be completed.
Measured: Baseline, Week 6
Pain Visual Analogue Scale (VAS)
It is a one-dimensional measure of pain intensity used to record patients' pain progression. It is a horizontal/vertical straight line of fixed length, (100 mm), beginning and ending with the extreme limits of the evaluated parameter, oriented from left (worst) to right (best).
Measured: Baseline, Week 6
Barthel Index (BI)
The Barthel Index is a measure of functional disability that assesses independence, mobility and the need for assistance in performing 10 common activities of daily living. Administration of the BI requires no special training or equipment.
Measured: Baseline, Week 6
EuroQol - 5 Dimension - 5 Level (EQ-5D-5L)
The EuroQol - 5 Dimension - 5 Level (EQ-5D-5L): is a self-report survey that measures the quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from 'No problems' through 'Extreme problems'.
Measured: Baseline, Week 6
Modified Ashworth scale (MAS)
It is a muscle tone assessment scale that measures resistance during passive soft-tissue stretching.
It is used as a simple measure of spasticity in patients with lesions of the Central Nervous System, it does not require any instrumentation and is quick to perform.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donders Centre for Neuroscience
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Verschure, Donders Centre for Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374927
- Sponsor's protocol ID
- PHRASE-2023
- Acronym
- PHRASE-2023
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 23 Apr 2024
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study
- ClinicalTrials.gov ID
- NCT06374927
- Acronym / sponsor ID
- PHRASE-2023 / PHRASE-2023
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Virtual Reality (VR), Augmented Reality (AR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Donders Centre for NeuroscienceUniversity, hospital or other
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 19 Apr 2024 (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.
The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge.
The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge.
Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientific principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home.
There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales.
The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience.
The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke.
Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks.
Detailed description
The rapid growth in the number of stroke patients needing care and rehabilitation requires an urgent scientifically grounded, and scalable response. There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. The PHRASE project combines theoretical neuroscience, and intervention protocols based on VR AR technology, the RGS, making it an excellent alternative to solving cognitive training.
The study is a feasibility study based on both quantitative and qualitative data collection. The general objective is to measure the usability of the system, including the user experience, adherence, and acceptance of the PHRASE system.
Specifically, the patient interacts with the RGSapp, a mobile app system that through the mobile registers the patient's movements and performance during the tasks to evaluate, reassess and update training protocols through AI-based algorithms. The clinicians have access to MIMS (Medical Information Management System) a portal that allows them to manage the patient profiles and deliver precise and objective metrics of the performance of the patient together with dashboards for therapists and clinicians. It facilitates diagnostics, monitoring, intervention scheduling, data storage and analytics, and reports and patient management.
The primary objective of this study is to measure the usability, adherence, user experience and acceptance of the PHRASE system during a six-week intervention.
Secondary outcome parameters will be assessed with clinical scales to explore the effectiveness of performing motor and cognitive assessments online and cognitive treatments provided through the RGSapp technology.
Investigators hypothesize that the personalized training supported by the PHRASE system is:
- Highly accepted by patients and clinicians. More specifically, it is expected that this approach to show good user experience and usability by the patients and ease patients' management by the clinicians.
- It increases the frequency and time spent with the rehabilitation program. More specifically, it is expected this approach shows good adherence to treatment.
- Explore the impact of the PHRASE system on cognitive assessment, function impairment, and quality of life.
STUDY DESIGN AND POPULATION: The study is a feasibility study based on both quantitative and qualitative data collection. The general objective is to measure the usability of the system, the user experience, the adherence, and the acceptance of the PHRASE system. Each clinical site will include 30-50 stroke patients (in any stroke stage), minimum age of 18 years. Over six weeks, the participants will integrate the PHRASE system into their daily routines, running parallel to their regular neurorehabilitation treatment.
STUDY SETTING: The study will be conducted in parallel in different European hospitals. The experimentation involves 3 different phases: Baseline assessment (T0) before the start of the trial, remote assessment (T1) and Final evaluation (T2) at the end of the trial, after 6 weeks.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Device: Rehabilitation Gaming System (VR-based mobile application)Stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients at different time points after stroke (acute, subacute, and chronic).
Key inclusion criteria (8 listed)
- Patients presenting an ischemic or intracerebral haemorrhagic stroke
- Age > 18 years old
- Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC≥2).
- Lesion localisation by clinical symptoms/signs.
- Able to sit on a chair or a wheelchair to interact with the RGS system.
Key exclusion criteria (8 listed)
- Presence of a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
- Severe cognitive capabilities that prevent the execution of the experiment, either evaluated by the MoCA < 19 or based on the clinician's opinion.
- Arteriovenous malformation or lesions not related to a stroke.
- Severe associated impairments such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia, or apraxia), major pain, or other neuromuscular impairments.
- Pre-stroke history of upper limb motor disability.
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 |
|---|---|---|
| Rehabilitation Gaming System (VR-based mobile application)The study intervention includes using the mobile phone technology RGSapp. This application integrates sensor data for delivering patient-tailored VR and AR-based training via gamified exercises for cognitive training. | Device | Stroke patients |
Primary outcome
Usability
Time frame: Week 6
Usability will be assessed at T2 by the System Usability Scale (SUS): The System Usability Scale is a reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, from 'Strongly agree' to 'Strongly disagree'.
User experience
Time frame: Week 6
User experience will be assessed at T2 by the User Experience Questionnaire (UEQ): the scales of the questionnaire cover a comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience aspects (originality, stimulation) are measured.
Adherence
Time frame: Week 6
Adherence will be assessed by the total time the RGSapp is used, in comparison to the advised RGSapp sessions for the entire duration of the study. Via the user ID, it is possible to monitor the patient's access to the RGSapp and the hours trained.
Acceptance
Time frame: Week 6
Acceptance will be assessed at T2 by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): the instrument is a self-administered questionnaire assessing user satisfaction with assistive technology products and associated services.
8 secondary outcomes
The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, Week 6
Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE)
Time frame: Baseline, Week 6
Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline, Week 6
Fatigue Severity Scale (FSS)
Time frame: Baseline, Week 6
Pain Visual Analogue Scale (VAS)
Time frame: Baseline, Week 6
Barthel Index (BI)
Time frame: Baseline, Week 6
EuroQol - 5 Dimension - 5 Level (EQ-5D-5L)
Time frame: Baseline, Week 6
Modified Ashworth scale (MAS)
Time frame: Baseline, Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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.
Anna Mura contact
4 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 Donders Centre for Neuroscience at 4 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 8 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, France, Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Verschure, PhD (31-631132710, paul.verschure@ru.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: Week 6). The study lists 4 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 23 Apr 2024.