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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smart phone App
conventional rehabilitation
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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
  • 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

Sites / Locations

  • Department of Occupational TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

smart phone intervention group

conventional group

Arm Description

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

stroke subjects receive conventional rehabilitation home program for 12 weeks

Outcomes

Primary Outcome Measures

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.
FUGL-MEYER ASSESSMENT-UE, FMA)
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke.
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.
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.
Motor Activity Log (MAL-28)
The Motor Activity Log (MAL) is a subjective measure of an individual's real life functional upper limb performance.
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2022
Last Updated
March 30, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05216094
Brief Title
Effects of Mhealth App on the Improvement of Upper Limb Function for Patients With Chronic Stroke
Official Title
Effects of Applying Task-oriented Practice Combined With Behavior Changes Strategy and Mhealth App on the Improvement of Upper Limb Function for Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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, and the evaluation contents include Fugl-Meyer Upper Limb Motor Function Scale, Grip Strength Assessment, Box and Block Test, MAL-28, Stroke Impact Scale and System Utility Scale. Data analysis included descriptive statistics, Repeated ANOVA, and correlation analysis. The results of this research are expected to develop a mobile health app that combines behavioral change technology and task-oriented exercise strategies, which can be applied to stroke patients at home or in the community to promote the execution of high-intensity and high-repetition upper limb motor function exercises, thereby improving upper limb and daily life. life function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
smart phone intervention group
Arm Type
Experimental
Arm Description
smart phone intervention group stroke subjects completed smart phone App tasks with affected upper limb or bilateral arm movement for 12 weeks
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
stroke subjects receive conventional rehabilitation home program for 12 weeks
Intervention Type
Other
Intervention Name(s)
smart phone App
Intervention Description
stroke subjects completed tasks-oriented program demoed in the smart phone app with affected upper limb or bilateral arm movement for 12 weeks
Intervention Type
Other
Intervention Name(s)
conventional rehabilitation
Intervention Description
stroke subjects receive conventional rehabilitation home program with smart phone app ,without task-oriented program demoed function, for 12 weeks
Primary Outcome Measure Information:
Title
Box and Block Test
Description
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.
Time Frame
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 )
Title
FUGL-MEYER ASSESSMENT-UE, FMA)
Description
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke.
Time Frame
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 )
Title
Grip Strength Assessment
Description
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.
Time Frame
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 )
Title
System Usability Scale(SUS)
Description
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.
Time Frame
only post-test(after 12 weeks' intervention)
Title
Motor Activity Log (MAL-28)
Description
The Motor Activity Log (MAL) is a subjective measure of an individual's real life functional upper limb performance.
Time Frame
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 )
Title
Stroke Impact Scale(SIS)
Description
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.
Time Frame
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 )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyh-Jong Chang, PhD
Phone
07-3121101
Ext
2644
Email
changotkmu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Jong Chang, PhD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Occupational Therapy
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JYH-JONG CHANG, PhD
Phone
07-3121101
Ext
2644
Email
changotkmu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD
IPD Sharing Time Frame
starting one year after publication
IPD Sharing Access Criteria
For Meta-analysis study
Citations:
PubMed Identifier
32107868
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32107868/
Description
Evaluation of a Game Based Tele Rehabilitation Platform for In-Home Therapy of Hand-Arm Function Post Stroke: Feasibility Study

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

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