Smart Phone for Stroke Upper Limb Motor Function Training

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: smart phone App rehabilitation; Other: conventional rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Department of Occupational Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smart phone intervention group; smart phone intervention group stroke subjects completed smart phone App tasks with affected arm or bilateral arm movement	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
Active Comparator: conventional group; stroke subjects receive conventional rehabilitation home program	Other: conventional rehabilitation; stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Jyh-Jong Chang, PhD, Kaohsiung Medical University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KMUHIRB-E(I)-20190067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: starting one year after publication
• IPD Sharing Access Criteria: For Meta-analysis study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No