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临床试验/NCT01414686
NCT01414686已完成2 期

Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke

University of South Carolina2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年5月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Balance (Berg Balance Scale)

研究概览

简要总结

More than half of individuals post-stroke have residual movement disabilities, including reduced mobility, balance, and increased risk of falling. There is a need for innovative, long-term and economically-feasible interventions for those with chronic stroke. Recently, a focus has been placed on the use of virtual reality and interactive gaming as a low cost and effective manner of treating movement disorders. Yet few studies have investigated interactive gaming platforms effect on balance following stroke. The proposed study is a randomized, single-blind, control group cross-over study for individuals with chronic stroke designed to examine an innovative therapeutic approach by investigating the effects of commercially-available gaming systems on balance, mobility and fear of falling in a sample of individuals with chronic motor deficits following stroke.

详细描述

Objective

To determine if playing active video games results in improved balance and motor performance.

Design: Randomized-matched, single-blind, control group cross-over study Setting: Laboratory Patients: Participants with chronic hemiparesis post-stroke were randomly assigned to a gaming group or normal activity control group.

Interventions: Gaming systems provided an interactive interface of real-time movement of either themselves or an avatar on the screen. Participants played games 1 hour/day, 4 days/week, for 5 weeks, totaling 20 hours of game-play. The intervention was strictly game-play without physical therapy. All games were played in standing position and trainers supervised to protect against loss of balance.

Measurements: Both groups were tested prior to and following the 5 weeks (post-test) and 3 months following the completion of the intervention/control. Outcome measures included: Fugl-Meyer Motor Exam, Single Leg Stance time, symmetrical weight bearing, Berg Balance Scale, Dynamic Gait Index, Timed Up and Go, Six Minute Walk, 3 Meter Walk, step length differential, and perception of recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Greater than 6 months following stroke
  • Ability to walk 10 feet with or without assistance
  • 18 years of age or older
  • Clinical presentation of unilateral hemiplegia post-stroke
  • Ability to follow simple two-step instructions

排除标准

  • Unable to ambulate 150 feet prior to stroke
  • History of serious chronic obstructive pulmonary disease or oxygen dependence
  • Severe weight bearing pain
  • Lower-extremity amputation
  • Non-healing ulcers on the lower extremity
  • Renal dialysis or end stage liver disease
  • Legal blindness or deafness or severe visual or hearing impairment
  • A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, or schizophrenia
  • Life expectancy less than one year
  • Severe arthritis or orthopaedic problems that limit passive ranges of motion of lower extremity: Knee flexion contracture of -10 degrees, Knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, ankle plantar flexion contracture > 15 degrees
  • History of deep venous thrombosis or pulmonary embolism within 6 months
  • Uncontrollable diabetes: diabetic coma, frequent insulin reactions
  • Severe hypertension with systolic > 200mmHg and diastolic > 110mmHg at rest
  • Intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded)
  • History of severe seizure disorder; other neurological conditions such as multiple sclerosis or Parkinson's Disease
  • Pain that is scored greater than 5 out of 10 on a visual analog scale and limits daily activity
  • Any health problems judged by their screening physician to put the client at significant risk of harm during the study

研究组 & 干预措施

Immediate Treatment Group

Experimental

干预措施: Commercially-Available Interactive Video Games (Other)

Delayed Treatment Group

No Intervention

结局指标

主要结局

Balance (Berg Balance Scale)

时间窗: change from pre to post and change from pre to follow-up (3 months)

Do determine the influence of active gaming on balance in individuals with chronic stroke

次要结局

  • balance (Berg Balance Scale)(post (5 weeks))
  • Participant Perception(Post test (5 weeks))

研究者

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

Stacy Fritz

Associate Professor

University of South Carolina

研究点 (2)

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