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临床试验/NCT01635582
NCT01635582已完成2 期

Effects of Home Based Computer Gaming Hand Exercise Regimen in People With Rheumatoid Arthritis (RA) or Osteoarthritis (OA) -A Randomized Controlled Pilot Trial

University of Manitoba2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks

研究概览

简要总结

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.

详细描述

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)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks

时间窗: Baseline and 6 weeks

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.

次要结局

  • Personal exercise log diary(End of 6 weeks of home exercise program)
  • Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Paddle game based hand function assessment tool at 6 weeks(Baseline and 6 weeks)

研究者

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

Dr. Tony Szturm

Associate Professor

University of Manitoba

研究点 (2)

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