NCT06885502

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
1mo left

Started Feb 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2025Jun 2026

Study Start

First participant enrolled

February 21, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 6, 2026

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 6, 2025

Last Update Submit

December 31, 2025

Conditions

StrokeStroke RehabilitationChronic Stroke PatientsPost Stroke Recovery

Keywords

StrokeARATMotor rehabilitationStroke rehabilitationTelemedicineVirtual Reality (VR)Augmented Reality (AR)Cognitive rehabilitationRehabilitation at homeeHealth technologyupper limbs

Outcome Measures

Primary Outcomes (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.

    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)

  • Cognitive Function

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

  • Depression and Mood Changes

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

  • Activity and Participation domain

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

  • Usability of RGSapp

    End of Treatment (T2, Week 6)

  • Validity of Remote Assessments Using RGSapp

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

Study Arms (2)

Experimental Group (RGS)

EXPERIMENTAL

The 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).

Device: RGS

Control Group

NO INTERVENTION

The 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.

Interventions

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.

Experimental Group (RGS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RoNeuro Institute for Neurological Research and Diagnostics

Cluj-Napoca, 400354, Romania

RECRUITING

Hospital Universitari Joan XXIII de Tarragona

Tarragona, 43005, Spain

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22871683BACKGROUND

  • 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.

    PMID: 22761551BACKGROUND

  • 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.

    PMID: 27506203BACKGROUND

  • 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.

    PMID: 32143674BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Santiago Brandi

CONTACT

34 931389642contact@eodyne.com

Anna Mura

CONTACT

anna3.mura@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, participants and clinicians involved in the intervention (except those conducting the clinical assessments) will be aware of the group allocation. Outcome assessors conducting the clinical evaluations at T0 (baseline), T2 (end-intervention), and T3 (follow-up) will remain blinded to the group allocation to minimize assessment bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 20, 2025

Study Start

February 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 6, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)RO(1)