Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
研究概览
简要总结
Stroke is a leading cause of long-term disability worldwide, with upper-limb impairment representing a major determinant of functional limitation and reduced independence. Conventional rehabilitation approaches are often limited by accessibility, intensity, and long-term adherence, highlighting the need for innovative, home-based solutions.
This study aims to evaluate the effectiveness of a personalized robotic telerehabilitation program for upper-limb recovery in individuals with post-stroke motor impairment. The intervention combines a wearable robotic device with a virtual reality-based platform, enabling patients to perform structured, task-oriented exercises in a home environment under remote supervision.
Participants will be allocated to either a robotic-assisted telerehabilitation program or a control condition based on virtual reality-based rehabilitation alone. Motor recovery will be assessed using standardized clinical scales, including the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), along with measures of functional performance, patient-reported outcomes, and treatment adherence.
By integrating robotic assistance with telemedicine, this study seeks to enhance rehabilitation intensity, improve patient engagement, and facilitate continuity of care beyond traditional clinical settings. The results are expected to support the development of accessible, personalized rehabilitation pathways for individuals with stroke-related upper-limb disability.
详细描述
This multicenter, prospective, randomized controlled trial aims to evaluate the effectiveness of a personalized telerehabilitation protocol integrating a wearable robotic device with a virtual reality (VR)-based platform in individuals with post-stroke upper-limb impairment.
Stroke-related upper-limb dysfunction significantly affects daily activities, social participation, and quality of life. According to the International Classification of Functioning, Disability and Health (ICF), participation is a key outcome; however, upper-limb disability represents a major barrier to inclusion.
Robotic rehabilitation and advanced technologies have demonstrated clinical effectiveness in improving motor function. However, their use is mainly limited to specialized centers. Home-based telerehabilitation enables continuity of care, enhances treatment intensity, and supports long-term recovery, while reducing the need for in-person sessions.
The intervention combines:
a wearable robotic device (EMOVO), a virtual reality telerehabilitation platform (VRRS Home Kit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is designed as an open-label trial with no masking. Due to the nature of the interventions, participants and study personnel (including therapists and investigators) cannot be blinded to group allocation.
Participants in the experimental group will use a wearable robotic device integrated with a virtual reality-based telerehabilitation platform, while participants in the control group will receive virtual reality-based telerehabilitation alone. The clear differences between interventions make blinding unfeasible.
Outcome assessments will be based on standardized clinical scales and objective measures to minimize potential 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
- •Adults aged 18 years or older
- •Diagnosis of stroke with residual upper-limb motor impairment
- •Upper-limb functional impairment defined by a Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 50
- •Ability to understand study procedures and provide written informed consent
- •Availability of a home environment suitable for telerehabilitation
排除标准
- •Presence of severe neurological or musculoskeletal disorders affecting the upper limb
- •Severe spasticity (Modified Ashworth Scale ≥3)
- •Severe upper-limb pain (Numerical Rating Scale >4)
- •Skin lesions, infections, or conditions preventing safe use of wearable devices
- •Participation in another interventional clinical trial
- •Any medical or cognitive condition that may interfere with compliance or safe participation in the study
研究组 & 干预措施
Robotic-Assisted Telerehabilitation for Upper Limb Recovery
Participants assigned to this arm will receive a home-based telerehabilitation program supported by a wearable robotic device integrated with a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period and includes passive and active-assisted upper-limb mobilization, grasping and releasing exercises, task-oriented activities, and interactive exergaming exercises. All sessions will be remotely supervised by a physiotherapist, with individualized adjustments based on participant performance and progression.
干预措施: Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation (Device)
Virtual Reality Telerehabilitation Without Robotic Support
Participants assigned to this arm will receive a home-based telerehabilitation program delivered through a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period and includes upper-limb mobilization exercises, task-oriented training, and interactive exergaming activities. All sessions will be remotely supervised by a physiotherapist to ensure correct execution and adherence to the rehabilitation protocol.
干预措施: Virtual reality-based rehabilitation platform without robotic assistance (Other)
结局指标
主要结局
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: Baseline to 4 weeks
The primary outcome is the change in upper-limb motor function measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), comparing baseline (pre-intervention) and post-treatment values. The FMA-UE is a validated, stroke-specific scale that evaluates motor recovery and functional impairment of the upper limb.
次要结局
- Box and Block Test (BBT)(Baseline to 4 weeks)
- Functional independence(Baseline to 4 weeks)
- Pain intensity and interference(Baseline to 4 weeks)
- Stroke-related quality of life(Baseline to 4 weeks)
- Muscle strength(Baseline to 4 weeks)
- Patient satisfaction(4 weeks)
- Usability(4 weeks)
- Safety and tolerability(Throughout study (up to 4 weeks))
- Treatment adherence and discontinuation(4 weeks)
研究者
Sara Liguori
Researcher
University of Campania Luigi Vanvitelli