Smart Phone for Stroke Upper Limb Motor Function Training

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: conventional rehabilitation; Other: smart phone App rehabilitation

• Registration Number: NCT05217329
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12-31
• Primary Completion: 2020-06-18
• Study Completion: 2021-03-26
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-26
• Last Update Submitted: 2022-01-26
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional group	conventional rehabilitation	stroke subjects receive conventional rehabilitation home program
smart phone intervention group	smart phone App rehabilitation	smart phone intervention group stroke subjects completed smart phone App tasks with affected arm or bilateral arm movement

Primary Outcome Measures

Name	Time	Method
FUGL-MEYER ASSESSMENT-UE, FMA)	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	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	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	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	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.

Trial Locations

Locations (1)

Department of Occupational Therapy; 🇨🇳 Kaohsiung, Taiwan