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临床试验/NCT05217329
NCT05217329已完成不适用

Smart Phone as an Assistive Technology for Stroke Upper Limb Motor Function Training - Feasibility and Treatment Effects Analysis

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
FUGL-MEYER ASSESSMENT-UE, FMA)

研究概览

简要总结

Stroke rehabilitation for stroke patients can enhance the upper and lower limb function, daily of daily activity improvement, and be beneficial to the family members' quality of life. Literature studies have supported the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to practice the mobile health model. Nevertheless, effects of tele-rehabilitation analysis for the proximal recovery of the stroke upper limbs still need to be explored. The main purpose of this research is to develop a smart phone with app system for stroke upper limb motor training, and further analyze its feasibility and treatment effects. The investigators randomly assigned chronic home stroke cases to the experimental group (n=20) and control group (n=20), each group received 8 weeks of treatment.

详细描述

Stroke rehabilitation (including occupational therapy and physical therapy) for stroke patients can enhance the upper and lower limb function, daily of daily activity improvement, and be beneficial to the family members' quality of life. Literature studies have supported the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to practice the mobile health model. This technology with remote rehabilitation have the important characteristics, including ease of use, high-intensity, repetitive exercises, and providing feedback information, to facilitate the recovery of training functions. Nevertheless, effects of tele-rehabilitation analysis for the proximal recovery of the stroke upper limbs still need to be explored. The main purpose of this research is to develop a smart phone with app system for stroke upper limb motor training, and further analyze its feasibility and treatment effects. The investigators randomly assigned chronic home stroke cases to the experimental group (n=20) and control group (n=20), each group received 8 weeks of treatment.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First onset
  • Unilateral Hemiplegia
  • No obvious cognitive impairment (Mini-Mental State Examination (MMSE) score > 23)
  • The FMA upper limb movement score is above 30 points
  • Those who have used a smartphone for more than 3 months before the onset of the disease or at present
  • Those who have no obvious vision loss and can read the text on mobile phones clearly
  • Those who own a smart phone

排除标准

  • Language barriers or aphasia
  • Other orthopedic diseases (such as severe shoulder pain, joint contractures) or nerve damage (such as peripheral nerve damage) that affect the movement of the upper limbs
  • Feel severe Absence, FMA sensory score <12 points
  • Other progressive diseases such as cancer, amyotrophic lateral sclerosis, multiple sclerosis, etc

结局指标

主要结局

FUGL-MEYER ASSESSMENT-UE, FMA)

时间窗: pre-test, post-test(Change from pre-test FUGL-MEYER ASSESSMENT-UE after 8 weeks' intervention)

Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke.

Box and Block Test

时间窗: pre-test, post-test(Change from pre-test Box and Block Test after 8 weeks' intervention)

The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.

Grip Strength Assessment

时间窗: pre-test, post-test(Change from pre-test Grip Strength Assessment after 8 weeks' intervention)

Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.

System Usability Scale

时间窗: only post-test(after 8 weeks' intervention)

The System Usability Scale, or SUS, is a simple survey that provides a high-level score for the usability of a product.

The Ruff 2 & 7 Selective Attention Test

时间窗: pre-test, post-test(Change from pre-test The Ruff 2 & 7 Selective Attention Test after 8 weeks' intervention)

The Ruff 2 and 7 Selective Attention Test (RSAT) is designed to measure selective attention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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