Home Based Computer Gaming Hand Exercise Regimen for People With Arthritis Affecting the Hands
2014年10月11日 更新者：Dr. Tony Szturm、University of Manitoba
Effects of Home Based Computer Gaming Hand Exercise Regimen in People With Rheumatoid Arthritis (RA) or Osteoarthritis (OA) -A Randomized Controlled Pilot Trial
The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand function, decrease pain/ stiffness and be feasible in people with Rheumatoid arthritis or Osteoarthritis affecting the hands.
研究概览
地位
完全的
详细说明
A novel computer gaming hand exercise regimen has been designed for people with Rheumatoid arthritis (RA) or Osteo arthritis (OA) affecting the hands. The design allows a broad range of common objects of daily life to be seamlessly transformed into 'therapeutic' input devices by instrumenting with a small motion sense mouse. Based on individual abilities and treatment needs, objects are selected to train specific fine/ gross dexterous functions. The object manipulations (therapeutic exercises) are then used to control and play any commercially available computer game, making practice challenging and engaging.
The study is of six weeks duration comparing the computer gaming and conventional hand exercises in thirty people diagnosed with RA or OA affecting the hands. The investigators hypothesize that the game based exercises will improve hand function and reduce pain/stiffness and be feasible compared to the conventional hand exercises.A mixed-effect repeated measures analysis of variance will be conducted to test pre to post treatment outcomes. This will be the first study to evaluate the therapeutic effects and feasibility of the computer gaming hand exercise regimen in people with RA or OA.
研究类型
介入性
注册 (实际的)
16
阶段
- 阶段2
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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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0T6
- University of Manitoba
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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
30年 至 70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:
- Men and women
- Aged between 30-70 years
- Clinical diagnosis of Rheumatoid arthritis or Osteoarthritis of hands according to American college of rheumatology criteria
- Must own a home computer and have basic working knowledge of computers.
- Present with scores ranging from 0-75 on self-reported hand function ability with the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
Exclusion Criteria:
- Severely deformed finger joints
- Neurological conditions of dominant side upper limb
- Trauma in wrist or hand
- Upper limb surgeries in previous six months
- Co-existing hand conditions in the dominant hand
- Problems with vision or hearing
- Recent changes in drug regimen (Disease modifying anti-rheumatic drugs (DMARDs) or corticosteroids <3 months)
- Major diseases of heart or lungs or liver
- DASH scores 0-75.
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：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Control group
Conventional hand exercise program
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Exercises targeted to improve finger range of motion and hand strength.The exercises will be performed 30 minutes,four times per week for six weeks
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实验性的：Experimental group
Computer gaming hand exercise regimen'
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Computer gaming hand exercise regimen using common objects of daily life.
The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for six weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks
大体时间：Baseline and 6 weeks
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The Arthritis Hand Function Test(AHFT) is an 11-item performance based test to measure grip and pinch strength, dexterity, applied strength and applied dexterity in people with arthritis.
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Baseline and 6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks
大体时间：Baseline and 6 weeks
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The DASH is a self-report questionnaire, with 30 items designed to measure functional ability and symptoms in people with any of several musculo skeletal disorders of the upper limb
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Baseline and 6 weeks
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Change from baseline in Paddle game based hand function assessment tool at 6 weeks
大体时间：Baseline and 6 weeks
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A novel, paddle game based hand function assessment tool has been developed designed to: 1) Objectively quantify the quality of finger hand movements (task performance) during manipulation of broad range of common objects independent of physical properties, anatomical requirements and task goal/context, 2) Quantify pain and joint stiffness during each object manipulation task, 3) Track changes in finger hand function over time and 4) Aid in clinical decision making
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Baseline and 6 weeks
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Personal exercise log diary
大体时间：End of 6 weeks of home exercise program
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Exercise compliance will be measured at the end of 6 weeks of home exercise program
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End of 6 weeks of home exercise program
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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。
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
- Szturm T, Peters JF, Otto C, Kapadia N, Desai A. Task-specific rehabilitation of finger-hand function using interactive computer gaming. Arch Phys Med Rehabil. 2008 Nov;89(11):2213-7. doi: 10.1016/j.apmr.2008.04.021.
- Lockery D, Peters JF, Ramanna S, Shay BL, Szturm T. Store-and-feedforward adaptive gaming system for hand-finger motion tracking in telerehabilitation. IEEE Trans Inf Technol Biomed. 2011 May;15(3):467-73. doi: 10.1109/TITB.2011.2125976.
- Andersen Hammond ER, Shay BL, Szturm T. Objective evaluation of fine motor manipulation-a new clinical tool. J Hand Ther. 2009 Jan-Mar;22(1):28-35; quiz 36. doi: 10.1197/j.jht.2008.06.006. Epub 2008 Aug 30.
- Hammond ER, Szturm T, Shay BL. Manipulation of objects with and without the use of the index finger: implications for digital amputations. J Hand Ther. 2010 Oct-Dec;23(4):352-59; quiz 360. doi: 10.1016/j.jht.2010.04.005. Epub 2010 Jul 6.
- Srikesavan CS, Shay B, Szturm T. Task-Oriented Training with Computer Games for People with Rheumatoid Arthritis or Hand Osteoarthritis: A Feasibility Randomized Controlled Trial. Games Health J. 2016 Oct;5(5):295-303. doi: 10.1089/g4h.2016.0005. Epub 2016 Sep 13.
- Srikesavan CS, Shay B, Robinson DB, Szturm T. Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial. Trials. 2013 Mar 9;14:69. doi: 10.1186/1745-6215-14-69.
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
2012年6月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2012年6月29日
首先提交符合 QC 标准的
2012年7月4日
首次发布 (估计)
2012年7月9日
研究记录更新
最后更新发布 (估计)
2014年10月15日
上次提交的符合 QC 标准的更新
2014年10月11日
最后验证
2014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.
Conventional hand exercise program的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的