Smart Phone for Stroke Upper Limb Motor Function Training
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smart phone App rehabilitation
conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Department of Occupational Therapy
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 arm or bilateral arm movement
stroke subjects receive conventional rehabilitation home program
Outcomes
Primary Outcome Measures
FUGL-MEYER ASSESSMENT-UE, FMA)
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke.
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.
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
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
The Ruff 2 and 7 Selective Attention Test (RSAT) is designed to measure selective attention.
Secondary Outcome Measures
Full Information
NCT ID
NCT05217329
First Posted
January 24, 2022
Last Updated
January 26, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05217329
Brief Title
Smart Phone for Stroke Upper Limb Motor Function Training
Official Title
Smart Phone as an Assistive Technology for Stroke Upper Limb Motor Function Training - Feasibility and Treatment Effects Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
March 26, 2021 (Actual)
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
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.
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
40 (Actual)
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 arm or bilateral arm movement
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
stroke subjects receive conventional rehabilitation home program
Intervention Type
Other
Intervention Name(s)
smart phone App rehabilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional rehabilitation
Intervention Description
stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)
Primary Outcome Measure Information:
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 8 weeks' intervention)
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 8 weeks' intervention)
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 8 weeks' intervention)
Title
System Usability Scale
Description
The System Usability Scale, or SUS, is a simple survey that provides a high-level score for the usability of a product.
Time Frame
only post-test(after 8 weeks' intervention)
Title
The Ruff 2 & 7 Selective Attention Test
Description
The Ruff 2 and 7 Selective Attention Test (RSAT) is designed to measure selective attention.
Time Frame
pre-test, post-test(Change from pre-test The Ruff 2 & 7 Selective Attention Test after 8 weeks' intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
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
31325288
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31325288/
Description
A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study
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Smart Phone for Stroke Upper Limb Motor Function Training
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