Smart Phone for Stroke Upper Limb Motor Function Training

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217329
• Other study ID #: KMUHIRB-E(I)-20190067
• Status: Completed
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: March 26, 2021

Study information

• Verified date: December 2018
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• smart phone App rehabilitation
stroke subjects use smart phone to complete therapeutic tasks 5 min/session total 8 sessions/day with affected arm or bilateral arm movement for 6 weeks
• conventional rehabilitation
stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)

Locations

Country	Name	City	State
Taiwan	Department of Occupational Therapy	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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

Outcome

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)

External Links

•   A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study