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

Official title

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

Overview

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.

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.

Interventions

• Device RGS
  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 trai

Primary outcome measures

• 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)]

Secondary outcome measures (5)

• Cognitive Function [Time frame: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)]
• Depression and Mood Changes [Time frame: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)]
• Activity and Participation domain [Time frame: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)]
• Usability of RGSapp [Time frame: End of Treatment (T2, Week 6)]
• Validity of Remote Assessments Using RGSapp [Time frame: Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Romania · 1 center

• RoNeuro Institute for Neurological Research and Diagnostics — Cluj-Napoca

Spain · 1 center

• Hospital Universitari Joan XXIII de Tarragona — Tarragona

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. PMID 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. PMID 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. PMID 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. PMID 32143674

Identifiers

NCT: NCT06885502 · PHRASE-2024 · 101058240

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗