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临床试验/NCT03292276
NCT03292276已完成不适用

Improving Hand Motor Function After Stroke: Role of Robotics

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Nine hole peg test

研究概览

简要总结

Two recent randomized clinical trials reported a significant contribute of Amadeo toward the recovery of hand motor function in acute stroke patients in association with physiotherapy and/or occupational therapy. However, no data are available in patients with chronic stroke, and the neurophysiological mechanisms underlying such clinical improvement need to be elucidated. Given that robotic devices harness brain plasticity to foster motor function recovery, a deeper understanding of the neurophysiological bases of Amadeo training could help clinician to realize patient-tailored rehabilitative training based brain plasticity knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in chronic phase after stroke. We estimated that 40 patients per group will be required to demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and randomized into two groups. The experimental group will be provided with Amadeo training. The Control group will be provided with occupational therapy executed by a trained physiotherapist.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic stroke patients at their first-ever supratentorial stroke

排除标准

  • presence of severe medical, psychiatric and cognitive abnormalities as to interfere with the treatment.
  • controindications to the device use.

研究组 & 干预措施

Amadeo training

Experimental

All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The robotic exercises will be carried in passive modality (15 minutes), passive/plus (15 minutes), assisted modality (15 minutes).

干预措施: Amadeo Training (Device)

occupational therapy

Active Comparator

All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The control group will receive the same amount of training by physiotherapist skilled in occupational tharapy.

干预措施: Amadeo Training (Device)

结局指标

主要结局

Nine hole peg test

时间窗: by 5 minutes

Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested. Only the hand being evaluated should perform the test. Hand not being evaluated is permitted to hold the edge of the board in order to provide stability. Scores are based on the time taken to complete the test activity, recorded in seconds. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second. Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container.

次要结局

  • cortical modifications related to movement preparation and execution after robot-assisted training(about 30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rocco Salvatore Calabrò

MD PhD

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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