跳至主要内容
临床试验/NCT04484571
NCT04484571Enrolling By Invitation不适用

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol

Azienda USL Toscana Nord Ovest2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月6日最近更新:
适应症

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

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

发起方
Azienda USL Toscana Nord Ovest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Posteraro

Head of North Area Rehabilitation Department

Azienda USL Toscana Nord Ovest

研究点 (2)

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