Stroke Clinical Trial
Official title:
Smart Phone as an Assistive Technology for Stroke Upper Limb Motor Function Training - Feasibility and Treatment Effects Analysis
Verified date | December 2018 |
Source | Kaohsiung Medical University Chung-Ho Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 26, 2021 |
Est. primary completion date | June 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Occupational Therapy | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital |
Taiwan,
Wu N, Gong E, Wang B, Gu W, Ding N, Zhang Z, Chen M, Yan LL, Oldenburg B, Xu LQ. A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study. JMIR Mh — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FUGL-MEYER ASSESSMENT-UE, FMA) | Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. | pre-test, post-test(Change from pre-test FUGL-MEYER ASSESSMENT-UE after 8 weeks' intervention) | |
Primary | Box and Block Test | 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. | pre-test, post-test(Change from pre-test Box and Block Test after 8 weeks' intervention) | |
Primary | Grip Strength Assessment | 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. | pre-test, post-test(Change from pre-test Grip Strength Assessment after 8 weeks' intervention) | |
Primary | System Usability Scale | The System Usability Scale, or SUS, is a simple survey that provides a high-level score for the usability of a product. | only post-test(after 8 weeks' intervention) | |
Primary | The Ruff 2 & 7 Selective Attention Test | The Ruff 2 and 7 Selective Attention Test (RSAT) is designed to measure selective attention. | pre-test, post-test(Change from pre-test The Ruff 2 & 7 Selective Attention Test after 8 weeks' intervention) |
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