Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
研究概览
简要总结
The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
详细描述
The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy towards functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol provide a functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
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
Indipendent assessor blinded on treatment provided
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper limb spasticity due to neurological impairment;
- •Cognitive abilities sufficient for understanding instructions;
- •Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).
排除标准
- •Unstable general clinical conditions;
- •Inability to keep sitting posture;
- •Tendon retractions limiting upper limb joints range of motion.
结局指标
主要结局
Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
时间窗: before and within 1 week after 4 weeks of treatment
It is a clinical scale used for the assessment of motor function in stroke patients
Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse
时间窗: Before and within 1 week after 4 weeks of treatment
It is a clinical scale for spasticity assessment
次要结局
- Change in Maximum Extension Torque (MET)(Before and within 1 week after 4 weeks of treatment)
- Change in Zero Torque Angle (ZTA)(Before and within 1 week after 4 weeks of treatment)
- Change in Joint Impedance (JIMP)(Before and within 1 week after 4 weeks of treatment)
研究者
Federico Posteraro
Head of North Area Rehabilitation Department
Azienda USL Toscana Nord Ovest
