Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
2013年10月25日 更新者：Chiara Mulé
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
研究概览
地位
完全的
条件
详细说明
We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.
We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.
研究类型
介入性
注册 (预期的)
35
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Bergamo
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Sarnico、Bergamo、意大利、24067
- Habilita, Ospedale di Sarnico
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- a history of acute phase of stroke (less than 12 months post onset),
- first stroke episode,
- no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
- no contracture of the affected wrist or fingers (Modified Ashworth<3),
- no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
- for P-ROM patients, the absence of active hand movements,
- for the A-ROM patients, the presence of active hand movements.
Exclusion Criteria:
- unstable medical disorders,
- active Complex Regional Pain Syndrome (CRPS),
- severe spatial neglect,
- aphasia,
- cognitive problems.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：A-ROM Continuous Passive Rehabilitation
The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week).
Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
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Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
其他名称：
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实验性的：P-ROM Continuous Passive Rehabilitation
The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week).
Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
|
Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from Baseline of Perimeter edema
大体时间：1 day after the treatment
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1 day after the treatment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from Baseline of Visual analogue scale (VAS)
大体时间：1 day after the treatment
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1 day after the treatment
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Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
大体时间：1 day after the treatment
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1 day after the treatment
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Change from Baseline of Range Of Motion (ROM)
大体时间：1 day after the treatment
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1 day after the treatment
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Clinical Global Impression (CGI)
大体时间：1 day after the treatment
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1 day after the treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Chiara Mulé, MD、Habilita, Ospedale di Sarnico
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
- Bell A, Muller M. Effects of kinesio tape to reduce hand edema in acute stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):283-8. doi: 10.1310/tsr2003-283.
- Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
- Yamaguchi T, Tanabe S, Muraoka Y, Imai S, Masakado Y, Hase K, Kimura A, Liu M. Effects of integrated volitional control electrical stimulation (IVES) on upper extremity function in chronic stroke. Keio J Med. 2011;60(3):90-5. doi: 10.2302/kjm.60.90.
- Kim EH, Chang MC, Seo JP, Jang SH, Song JC, Jo HM. The effect of a hand-stretching device during the management of spasticity in chronic hemiparetic stroke patients. Ann Rehabil Med. 2013 Apr;37(2):235-40. doi: 10.5535/arm.2013.37.2.235. Epub 2013 Apr 30. Erratum In: Ann Rehabil Med. 2013 Jun;37(3):459. Jang, Min Cheol [corrected to Chang, Min Cheol].
- Bialosky JE, George SZ, Bishop MD. How spinal manipulative therapy works: why ask why? J Orthop Sports Phys Ther. 2008 Jun;38(6):293-5. doi: 10.2519/jospt.2008.0118. Epub 2008 May 27. No abstract available.
- Kong KH, Chua KS, Lee J. Symptomatic upper limb spasticity in patients with chronic stroke attending a rehabilitation clinic: frequency, clinical correlates and predictors. J Rehabil Med. 2010 May;42(5):453-7. doi: 10.2340/16501977-0545.
- Lundstrom E, Smits A, Terent A, Borg J. Time-course and determinants of spasticity during the first six months following first-ever stroke. J Rehabil Med. 2010 Apr;42(4):296-301. doi: 10.2340/16501977-0509.
- Villafane JH, Valdes K. Combined thumb abduction and index finger extension strength: a comparison of older adults with and without thumb carpometacarpal osteoarthritis. J Manipulative Physiol Ther. 2013 May;36(4):238-44. doi: 10.1016/j.jmpt.2013.05.004. Epub 2013 May 27.
- Chang CW, Kuo LC, Cheng YT, Su FC, Jou IM, Sun YN. Reliable model-based kinematics analysis system for articulated fingers. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:4675-8. doi: 10.1109/IEMBS.2007.4353383.
- Borboni A, Villafane JH, Mulle C, Valdes K, Faglia R, Taveggia G, Negrini S. Robot-Assisted Rehabilitation of Hand Paralysis After Stroke Reduces Wrist Edema and Pain: A Prospective Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):21-30. doi: 10.1016/j.jmpt.2016.10.003. Epub 2016 Nov 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年9月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2013年9月2日
首先提交符合 QC 标准的
2013年9月2日
首次发布 (估计)
2013年9月6日
研究记录更新
最后更新发布 (估计)
2013年10月28日
上次提交的符合 QC 标准的更新
2013年10月25日
最后验证
2013年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.