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StrokePHRASE-2024NCT06885502

Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)

A study testing RGS in people with Stroke and Stroke Rehabilitation, run by Eodyne Systems SL at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a multicentric randomized controlled trial evaluating the effectiveness of digital technology, specifically a smartphone with integrated VR-and AR-based intervention, for at-home rehabilitation after stroke. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RGS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesin 2 countries
Study dates
21 Feb 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Patients presenting an ischemic or intracerebral haemorrhagic stroke, ≥ 3 months post-stroke.
  • Age > 18 years old
  • Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC >2).
  • ARAT: <50, inclusive, to avoid ceiling effects while allowing room for improvement.
  • 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 study, evaluated by the MoCA < 19 or based on the clinician's opinion.
  • Pre-stroke history of upper limb motor disability.
  • Unable to use the RGS independently, according to the clinician's observations, and needing more support from a caregiver to use the RGS.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Santiago Brandi contact

34 931389642

contact@eodyne.com

Anna Mura contact

anna3.mura@gmail.com

2 sites in 2 countries

Romania1 site, 1 recruiting

  • RoNeuro Institute for Neurological Research and Diagnostics

    Cluj-Napoca, 400354

    Fior-Dafin Mureşanu, Prof. Dr., 0374 46 22 22, roneuro.research@brainscience.ro

    Fior-Dafin Mureşanu

    Recruiting

Other trials in Romania

Spain1 site, 1 recruiting

  • Hospital Universitari Joan XXIII de Tarragona

    Tarragona, 43005

    Rosa M San Segundo Mozo, 977295800, rosamaria.sansegundo@urv.cat

    Rosa M San Segundo Mozo

    Recruiting

Other trials in Spain

About this study

Official title: Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE): A Randomized Clinical Trial

This study is a multicentric randomized controlled trial evaluating the effectiveness of digital technology, specifically a smartphone with integrated VR-and AR-based intervention, for at-home rehabilitation after stroke. The study focuses on combined motor and cognitive training for patients in the late subacute and chronic phases post-stroke. The intervention is provided through the Rehabilitation Gaming System application RGSapp, a goal-oriented, first-person virtual reality (VR) and augmented reality (AR) mobile application for upper limb rehabilitation. A total of seventy participants will be randomly assigned (1:1 ratio) to either the RGSapp intervention or conventional therapy/standard of care for six weeks. The primary outcome is motor function improvement (upper limb), assessed using the Action Research Arm Test (ARAT). Secondary outcomes include changes in cognitive function, depression, usability, adherence, validity of remote assessments, and healthcare costs.

Read the detailed description

Stroke-induced motor and cognitive impairments often worsen after hospital discharge due to limited access to rehabilitation, creating a cycle of non-use and functional loss ("rehabilitation in vain"). The PHRASE system aims to counteract this by providing patient-tailored, continuous rehabilitation at home using the Rehabilitation Gaming System (RGS). This integrated approach leverages VR/AR technology, prognostic tools, and data-driven decision-making to improve motor and cognitive function, reduce costs, and enhance patient independence.

The study seeks to validate the effectiveness of the PHRASE system, focusing on its impact on motor and cognitive recovery and its use as a diagnostic and prognostic tool. It hypothesizes that combining the RGS application with conventional therapy will lead to better recovery outcomes compared to conventional therapy alone.

This randomized clinical trial (RCT) will compare the RGS-based intervention to conventional therapy in stroke patients in Spain and Romania. Participants will undergo a six-week intervention involving daily 20-30-minute RGS sessions. Assessments are at baseline, mid-study (3 weeks), end of study (6 weeks) and follow-up (14 weeks). Data will be collected on motor and cognitive function, quality of life, usability, and patient/therapist experiences.

Participants must be stroke survivors (>3 months post-stroke), aged >18, with mild to moderate upper-limb impairment (ARAT <50) and minimal smartphone experience.

The RGS-based PHRASE approach offers a scalable, cost-effective solution for continuous rehabilitation, improving patient recovery, quality of life, and reducing healthcare costs. The study aims to validate its clinical validity in real-world settings.

Being tested
RGS
Keywords
Stroke, ARAT, Motor rehabilitation, Stroke rehabilitation, Telemedicine, Virtual Reality (VR), Augmented Reality (AR), Cognitive rehabilitation, Rehabilitation at home, eHealth technology, upper limbs
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RGSDevice

    The standardized intervention schedule consists of 20-30-minute daily training sessions (including weekends) for 6 weeks, in addition to the prescribed conventional therapy (Standard of Care, SoC). Each session includes 4 to 6 exercises, each lasting approximately 5 minutes. To promote variability and engagement, at least one exercise will be replaced every week based on the participant's progress. Participants are encouraged to train more than the prescribed duration if desired. The RGSapp training will take place at home, and patients will use a smartphone. An optional wearable device (smartwatch) will be used to remotely monitor the use of the paretic upper arm for the duration of the trial. Regular check-ins by clinicians will monitor adherence, adjust the intervention if needed, and ensure the participants' safety.

Study groups in NCT06885502
Study groupRoleWhat they receive
Experimental Group (RGS)ExperimentalThe standardized intervention schedule consists of daily 20-30-minute training sessions with the RGSapp, conducted at home, including weekends, for 6 weeks. This intervention is provided in addition to the prescribed conventional therapy (Standard of Care, SoC).
Receives: Device: RGS
Control GroupNo interventionThe control group participants will be assessed at Baseline (T0), Week 6/End of Treatment (T2), and Follow-up at Week 14 (T3). The outcome measures will be the same as in the intervention group, including assessments of motor function, cognitive function, depression, activity participation, usability, and healthcare costs. No VR or AR-based interventions will be provided to the control group during the study period.

What is being measured

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

  1. Upper Limb Function (Motor Recovery)

    The primary objective of this study is to assess the effect of a mobile technology (RGSapp) intervention on upper limb motor function compared to Standard of Care (SoC). Upper limb function will be evaluated using the Action Research Arm Test (ARAT).

    Action Research Arm Test (ARAT) (Lyle, 1981): It is a functional assessment tool comprising 19 items, with a maximum score of 57. These items are organized into four subscales: grasp, grip, pinch, and gross movement. Each item is scored on a 4-point ordinal scale: 0 (cannot perform the task) to 3 (performs the task normally). Higher scores indicate better outcomes, reflecting greater arm function.

    Measured: Assessments will be conducted at Baseline (T0), End of Treatment (T2, Week 6), and Follow-up (T3, Week 14, 2-months follow-up)

Secondary outcomes (5)

  1. Cognitive Function

    Post-stroke cognitive impairment, particularly deficits in attention, processing speed, executive function, and visual perception, which are key factors in long-term disability [Lesniak M. et al., 2008].

    Test of Attentional Performance (TAP) (Zimmermann \& Fimm, 2004): It is a comprehensive battery designed to assess various aspects of attentional performance, including sustained attention, selective attention, and cognitive flexibility. It includes multiple subtests, with each scored based on accuracy and response time. Higher scores indicate better attentional capacity, providing detailed insights into different attention processes and cognitive functioning.

    Measured: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)

  2. Depression and Mood Changes

    This outcome will assess depression and mood changes using the following validated tool:

    Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960): It is a clinician-administered questionnaire used to evaluate the severity of depressive symptoms over the previous week, based on a structured or unstructured interview. The scale consists of 17 items, with scores ranging from 0 to 53. Higher scores indicate more severe depression, with 0-7 considered normal, 8-16 indicating mild depression, 17-23 indicating moderate depression, and 24 or above indicating severe depression.

    Measured: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)

  3. Activity and Participation domain

    We will further assess the impact of stroke on parameters that strongly influence activity and participation (Activities of daily living, mobility, emotion, strength, and communication). We will use:

    Quality of Life (EQ-5D-5L) (Devlin \& Brooks, 2017): It is a standardized tool for measuring health-related quality of life. It includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale (1 - no problems to 5 - extreme problems). The final score is based on the combination of responses across dimensions, with higher scores reflecting better overall quality of life.

    Fatigue Severity Scale (FSS) (Krupp et al., 1988): It is a 9-item self-report questionnaire used to assess fatigue severity in individuals with chronic diseases. Each item is rated on a 1 to 7 scale, where 1 indicates no fatigue and 7 represents severe fatigue. Higher scores indicate more severe fatigue.

    Measured: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)

  4. Usability of RGSapp

    This outcome will assess the usability of the RGSapp using the System Usability Scale (SUS).

    System Usability Scale (SUS) (Brooke, 1996): It is a 10-item questionnaire using a five-point Likert scale (Strongly Agree to Strongly Disagree) to assess the usability of products and services, including hardware, software, mobile devices, websites, and applications. Scores range from 0 to 100, with higher scores indicating better usability. A score above 68 is considered above average, below 50 suggests poor usability, and a score above 80 indicates excellent usability.

    Measured: End of Treatment (T2, Week 6)

  5. Validity of Remote Assessments Using RGSapp

    This outcome will assess the correlation between remote assessments using RGSapp and standard clinical evaluations of motor and cognitive function. Specifically, performance data collected through RGSapp will be compared with established clinical assessment tools, including the Action Research Arm Test (ARAT), Fugl-Meyer Assessment for Upper Extremity (FMA-UE), and Test for Attentional Performance (TAP) subtests.

    Measured: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start21 Feb 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885502
Sponsor's protocol ID
PHRASE-2024
Other IDs
101058240
Acronym
PHRASE-2024
Status last verified
Mar 2025
First submitted
6 Mar 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. Only summary statistics, or disidentified datasets that pose no risk of re-identification can be shared with researchers not involved in the study to ensure transparency and reproducibility without compromising participant confidentiality.

Publications

  • Cameirao MS, Badia SB, Duarte E, Frisoli A, Verschure PF. The combined impact of virtual reality neurorehabilitation and its interfaces on upper extremity functional recovery in patients with chronic stroke. Stroke. 2012 Oct;43(10):2720-8. doi: 10.1161/STROKEAHA.112.653196. Epub 2012 Aug 7.

    PubMed 22871683

  • Hidaka Y, Han CE, Wolf SL, Winstein CJ, Schweighofer N. Use it and improve it or lose it: interactions between arm function and use in humans post-stroke. PLoS Comput Biol. 2012 Feb;8(2):e1002343. doi: 10.1371/journal.pcbi.1002343. Epub 2012 Feb 16.

    PubMed 22761551

  • Ballester BR, Maier M, San Segundo Mozo RM, Castaneda V, Duff A, M J Verschure PF. Counteracting learned non-use in chronic stroke patients with reinforcement-induced movement therapy. J Neuroeng Rehabil. 2016 Aug 9;13(1):74. doi: 10.1186/s12984-016-0178-x.

    PubMed 27506203

  • Maier M, Ballester BR, Leiva Banuelos N, Duarte Oller E, Verschure PFMJ. Adaptive conjunctive cognitive training (ACCT) in virtual reality for chronic stroke patients: a randomized controlled pilot trial. J Neuroeng Rehabil. 2020 Mar 6;17(1):42. doi: 10.1186/s12984-020-0652-3.

    PubMed 32143674

Questions about this trial

What is this clinical trial studying?

A study testing RGS in people with Stroke and Stroke Rehabilitation, run by Eodyne Systems SL at 2 sites in 2 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 4 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Romania, 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Santiago Brandi (34 931389642, contact@eodyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Limb Function (Motor Recovery) (time frame: Assessments will be conducted at Baseline (T0), End of Treatment (T2, Week 6), and Follow-up (T3, Week 14, 2-months follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885502, which also lists 4 linked publications.

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 6 Jan 2026.

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