"Comparison of Outcomes of Physiotherapist- and Robot-Assisted Upper Limb Therapy and Their Association With Muscle Tone and Motor Function in Subacute Stroke Patients"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
研究概览
简要总结
This study aims to compare the outcomes of upper limb motor therapy conducted by a physiotherapist with robot-assisted therapy using the Luna EMG device in patients in the subacute phase after stroke. Additionally, the study will examine the correlation between changes in muscle tone and motor function improvement. The randomized controlled trial will be conducted at the Rehabilitation Department of the T. Marciniak Lower Silesian Specialist Hospital in Wrocław, Poland. Two groups (robot-assisted vs. conventional therapy) will perform identical sets of movements with matched repetition counts over a 6-week therapy period. Functional improvement will be assessed using Fugl-Meyer Upper Extremity Assessment (FMA-UE), Box and Block Test (B&BT), EQ-5D-5L, and MyotonPro measurements.
详细描述
Stroke often leads to upper limb motor impairment, spasticity, and reduced independence. Robot-assisted rehabilitation, including devices like Luna EMG, may increase therapy intensity and patient motivation through feedback and movement intention detection via EMG signals.
This interventional study includes 50 participants post-stroke, randomly assigned to either robot-assisted therapy (Luna EMG) or conventional physiotherapist-led therapy. Both groups receive standard rehabilitation (75 minutes/day), with an additional 45-minute targeted upper limb training session. Sessions are conducted 5 days a week for 6 weeks.
Muscle tone will be assessed using the Modified Ashworth Scale and biomechanical parameters (stiffness, oscillation) with MyotonPro. Motor performance will be evaluated using the Fugl-Meyer Assessment (FMA-UE) and the Box and Block Test (B&BT). Quality of life and pain perception will also be measured using the EQ-5D-5L and a numeric rating scale (NRS).
Outcome measures will be collected at baseline, after 3 weeks, after 6 weeks of therapy, and 3 weeks post-intervention to evaluate both immediate and short-term effects of the intervention. This study seeks to identify whether robotic rehabilitation offers measurable advantages over traditional methods in early post-stroke recovery.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcomes assessor is blinded. Functional and quality of life assessments (e.g., FMA-UE, Box and Blocks Test, EQ-5D-5L) are conducted by an independent physiotherapist who is not involved in treatment delivery and remains unaware of the participants' group assignments.
Due to the nature of the intervention, participants are aware of their treatment allocation (robot-assisted vs. therapist-assisted training). Similarly, physiotherapists delivering the robotic or therapist-assisted upper limb training (based on 50 EMG-triggered or assisted repetitions) are necessarily aware of group allocation. However, physiotherapists delivering the standard rehabilitation program (common to both groups) are not informed about group assignment and are considered blinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90
- •First-ever ischemic or hemorrhagic stroke within 6 weeks prior to enrollment
- •Stable medical condition
- •Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 94
- •Mini-Mental State Examination (MMSE) ≥ 23
- •Signed informed consent
排除标准
- •Fixed contractures in upper limb
- •MAS ≥ 3 in any upper limb muscle
- •Severe vision/hearing problems
- •Severe dysphagia or respiratory issues
- •Myasthenia or myasthenic syndrome
研究组 & 干预措施
Robot-assisted training (Luna EMG)
A robotic rehabilitation device using EMG-triggered movement assistance for upper limb recovery after stroke.
干预措施: Luna EMG (Device)
Therapist-assisted training
A physiotherapist assists the participant in performing 4 specific upper limb movements (50 repetitions each), matching the robotic training protocol.
干预措施: Therapist-assisted upper limb training (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Functional motor recovery of the affected upper limb, scored 0-66 (or 94, depending on version used). Higher scores indicate better function.
次要结局
- Box and Blocks Test (B&BT)(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- EQ-5D-5L(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Muscle Tone - Modified Ashworth Scale (MAS)(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Muscle Oscillation Frequency Measured by MyotonPRO(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Muscle Stiffness Measured by MyotonPRO(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Muscle Elasticity Measured by MyotonPRO(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Muscle Relaxation Time Measured by MyotonPRO(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Muscle Creep Measured by MyotonPRO(Baseline, Week 3, Week 6, and 3 weeks after therapy completion)
- Pain Intensity (NRS 0-10)(Baseline, Week 3, Week 6, and 3 weeks after therapy completion (Rest and activity))
研究者
Denis Moskiewicz
M.Sc., Assistant Lecturer, Dept. of Neurological and Pediatric Physiotherapy
Wroclaw University of Health and Sport Sciences