Effects of Mhealth App on the Improvement of Upper Limb Function for Patients With Chronic Stroke

NCT05216094 | Completed

• 1 other identifier: KMUHIRB-E(I)-20200437
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose is to develop a mobile health app that combines behavioral change technology and task-oriented exercise strategies to provide a technology-assisted training system for upper limb motor function in home stroke cases, and to analyze its feasibility and therapeutic benefits. It is estimated that 50 chronic stroke cases will be recruited and randomly assigned to the experimental group (n=25) and the control group (n=25). The experimental group received a 12-week action health App combined with behavioral change technology and task-oriented upper limb exercise strategy intervention. The control group received a 12-week sham control and a traditional home rehabilitation intervention program. Both groups received pre-test, post-test (12 weeks) and follow-up assessment (4 weeks). This study will adopt a double-blind evaluation design.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• 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 12 weeks' intervention), and follow-up(Change from post-test Box and Block Test at one month )

• 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 12 weeks' intervention), and follow-up(Change from post-test FUGL-MEYER ASSESSMENT-UE at one month )

• 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 12 weeks' intervention), and follow-up(Change from post-test Grip Strength Assessment at one month )

• System Usability Scale(SUS)

  The System Usability Scale, is a simple survey that provides a high-level score for the usability of a product. The score is a value between 0 and 100, with higher values indicating better usability.

  only post-test(after 12 weeks' intervention)

• Motor Activity Log (MAL-28)

  The Motor Activity Log (MAL) is a subjective measure of an individual's real life functional upper limb performance.

  pre-test, post-test(Change from pre-test Motor Activity Log after 12 weeks' intervention), and follow-up(Change from post-test Motor Activity Log at one month )

• Stroke Impact Scale(SIS)

  The purpose of this questionnaire is to evaluate how stroke has impacted your health and life. The score is a value between 0 and 100, with higher values indicating better recover.

  pre-test, post-test(Change from pre-test Stroke Impact Scale after 12 weeks' intervention), and follow-up(Change from post-test Stroke Impact Scale at one month )

Study Arms (2)

smart phone intervention group

EXPERIMENTAL

smart phone intervention group stroke subjects completed smart phone App tasks with affected upper limb or bilateral arm movement for 12 weeks

Other: smart phone App

conventional group

ACTIVE COMPARATOR

stroke subjects receive conventional rehabilitation home program for 12 weeks

Other: conventional rehabilitation

Interventions

smart phone App OTHER

stroke subjects completed tasks-oriented program demoed in the smart phone app with affected upper limb or bilateral arm movement for 12 weeks

smart phone intervention group

conventional rehabilitation OTHER

stroke subjects receive conventional rehabilitation home program with smart phone app ,without task-oriented program demoed function, for 12 weeks

conventional group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>20, and 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, and there are partial extension movements of the affected fingers and wrists
• Ability to operate a smartphone independently before or at present
• Those who have no obvious vision loss and can read mobile phone text clearly

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
• People with abnormal cardiopulmonary function who are not suitable for active sports
• 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)

• Szturm T, Imran Z, Pooyania S, Kanitkar A, Mahana B. Evaluation of a Game Based Tele Rehabilitation Platform for In-Home Therapy of Hand-Arm Function Post Stroke: Feasibility Study. PM R. 2021 Jan;13(1):45-54. doi: 10.1002/pmrj.12354. Epub 2020 Apr 13.

  PMID: 32107868 RESULT

Related Links

• Evaluation of a Game Based Tele Rehabilitation Platform for In-Home Therapy of Hand-Arm Function Post Stroke: 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: January 31, 2022
• Study Start: February 8, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 29, 2023

Record last verified: 2022-02

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)