Clinical trial NCT05217329: Smart Phone for Stroke Upper Limb Motor Function Training
Official title: Smart Phone as an Assistive Technology for Stroke Upper Limb Motor Function Training - Feasibility and Treatment Effects Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: FUGL-MEYER ASSESSMENT-UE, FMA)
timeFrame: pre-test, post-test(Change from pre-test FUGL-MEYER ASSESSMENT-UE after 8 weeks' intervention)
measure: Box and Block Test
timeFrame: pre-test, post-test(Change from pre-test Box and Block Test after 8 weeks' intervention)
measure: Grip Strength Assessment
timeFrame: pre-test, post-test(Change from pre-test Grip Strength Assessment after 8 weeks' intervention)
measure: System Usability Scale
timeFrame: only post-test(after 8 weeks' intervention)
measure: The Ruff 2 & 7 Selective Attention Test
timeFrame: pre-test, post-test(Change from pre-test The Ruff 2 & 7 Selective Attention Test after 8 weeks' intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Occupational Therapy
Study officials:
affiliation: Kaohsiung Medical University
name: Jyh-Jong Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Mhealth Uhealth. 2019 Jul 19;7(7):e13503. doi: 10.2196/13503.