Smart Phone for Stroke Upper Limb Motor Function Training

NCT05217329 | Completed

• 1 other identifier: KMUHIRB-E(I)-20190067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

smart phone intervention group

EXPERIMENTAL

smart phone intervention group stroke subjects completed smart phone App tasks with affected arm or bilateral arm movement

Other: smart phone App rehabilitation

conventional group

ACTIVE COMPARATOR

stroke subjects receive conventional rehabilitation home program

Other: conventional rehabilitation

Interventions

smart phone App rehabilitation OTHER

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

smart phone intervention group

conventional rehabilitation OTHER

stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)

conventional group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Department of Occupational Therapy

Kaohsiung City, 807, Taiwan

Location

Related 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 Mhealth Uhealth. 2019 Jul 19;7(7):e13503. doi: 10.2196/13503.

  PMID: 31325288 RESULT

Related Links

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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jyh-Jong Chang, PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 1, 2022
• Study Start: December 31, 2018
• Primary Completion: June 18, 2020
• Study Completion: March 26, 2021
• Last Updated: February 1, 2022

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: starting one year after publication
• Access Criteria: For Meta-analysis study

Locations

TW (1)