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临床试验/NCT03716206
NCT03716206Unknown不适用

Effects of Exergames on Post-stroke Shoulder Pain and Motor Function

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Brief Pain Inventory - Short Form

研究概览

简要总结

This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke.

详细描述

Background and Purpose: Stroke is a major cerebrovascular disorder causing various symptoms in the world. A substantial portion of those surviving from stroke typically experience neurological sequelae and stroke-related complications. Post stroke shoulder pain is a sensory disturbance is one of a common complication in patients with chronic stroke and may adversely affect patients' quality of life. Nowadays, exergame has been explored as an adjunct therapy for the management of pain for a number of conditions. This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke. Method: This is a randomized controlled trail. Sixty subjects with poststroke shoulder pain will be recruited and randomized into either the exergame (experimental) group or conventional (control) group. The intervention is one hour per day, four or five days per week for three weeks. The primary outcomes are Visual Analogue Scale, and Brief Pain Inventory - Short Form. The secondary outcomes are Fugl-Meyer Assessment for Upper Limb Extremity, Wolf motor function test and Shoulder Pain and Disability Index.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral hemiplegia caused by stroke
  • Modified Ashworth Scale ≤2。
  • Mini-Mental State Examination ≥24。
  • Shoulder pain 。

排除标准

  • Shoulder joint contructure
  • Forzen shoulder
  • Dizzness, lesion of auditory and vision.

研究组 & 干预措施

exergames group

Experimental

The exergames intervention is one hour per day, four or five days per week for three weeks.

干预措施: Exergame (Device)

conventional group

Active Comparator

The conventional group intervention is one hour per day, four or five days per week for three weeks.

干预措施: Physical therapy (Other)

结局指标

主要结局

Brief Pain Inventory - Short Form

时间窗: Change from Baseline at 7 weeks

To assess the severity of pain and the impact of pain on daily functions. The Brief Pain Inventory - Short Form assess severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. It is available in a short (nine items) form.

Visual analogue scale

时间窗: Change from Baseline at 7 weeks

The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best).

次要结局

  • Wolf motor function test(Change from Baseline at 7 weeks)
  • Fugl-Meyer Assessment(Change from Baseline at 7 weeks)

研究者

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

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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