Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Upper Limb Function (Motor Recovery)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Group (RGS)
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).
干预措施: RGS (Device)
Control Group
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.
结局指标
主要结局
Upper Limb Function (Motor Recovery)
时间窗: Assessments will be conducted at Baseline (T0), End of Treatment (T2, Week 6), and Follow-up (T3, Week 14, 2-months follow-up)
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.
次要结局
- 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))