Smartphone-based Balance Assessment System for Chronic Stroke
Development of a Smartphone-based Balance Assessment System for Subjects With Chronic Stroke
1 other identifier
interventional
300
1 country
1
Brief Summary
Background: Stroke is the 4th deadly disease in Taiwan, 2016. Long term disabilities, balance impairments and limitations of activities of daily living are common characteristics of stroke. Balance assessment and training play an important role in stroke rehabilitation. However, there are some limitations. Clinical assessments (functional scales) could not avoid some errors caused by subjective observations from different test givers; instrumental assessments (force plates, Biodex system) are complex to approach, not easy to use, and difficult to get. Balance training could not meet the expected effectiveness due to inconvenient transportations, forgotten home programs, and time limitation caused by huge amount of patients with insufficient therapists. Smartphones had been used for health promoting and sport training. The balance training related applications could be found at Google Play store, but clinically proved effective App and stroke-designed App has not yet existed. The balance rehabilitation of stroke sufferers will be benefited if there is an easy-use and effective App that supports balance assessment and personalized training by combining the convenience and powerfulness of smartphones. Purpose: The purposes of this study are: Year 1 Develop a smartphone-based application to assess and train static balance for stroke sufferers, and evaluate the feasibility of the application; Year 2 Develop a smartphone-based application to assess and train dynamic balance for stroke sufferers, and evaluate the feasibility of the application; Year 3 Build a static and dynamic balance performance standard by recruiting healthy subjects, then evaluate the training effects of the application on balance performance of stroke sufferers. Methods: Android smartphones will be used to analyze the balance performance by collecting acceleration and angular velocity data from the built-in sensors. Static balance assessment and training system will be developed in the first year. The system will assess balance ability by testing the performance under different standing conditions, then provide a training plan according to the assessment result. Dynamic balance assessment and training system will be developed in the second year. The system will execute limits of stability test to assess dynamic balance, then provide a training plan according to the assessment result. Validity and reliability will be tested in the first and second year, by comparing the smartphone assessment result with Berg balance scale, force plate, and Biodex balance system. In the third year, we will recruit healthy subjects to create a balance performance standard, then recruit chronic stroke subjects to evaluate the training effect of the App by comparing with traditional rehabilitation therapy. Expected Results \& Contribution When the study is completed, several valuable contributions will be provided. These include (1) developing a smartphone application which can be used to assess and rehabilitate static and dynamic balance functions on stroke sufferers; (2) evaluating the feasibility and the training effects of the smartphone application, and providing evidence-based results for scientific paper publication; (3) clinically offering an easy-used and effective tool for clinicians and subjects with stroke to evaluate and improve balance performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started May 2018
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2018
CompletedFirst Submitted
Initial submission to the registry
July 14, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedJuly 12, 2022
April 1, 2022
4.1 years
July 14, 2019
July 10, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Balance performance assessed by smartphone-based balance test
The data of smartphone built-in accelerometer and gyroscope will be measured and calculated
4 weeks
Balance performance assessed by force plates
The movement of center of pressure (COP) will be measured and calculated
4 weeks
Balance performance assessed by Berg balance scale
The score of Berg balance scale will be measured
4 weeks
Study Arms (4)
Healthy Adult
NO INTERVENTIONbalance assessment
Stroke
NO INTERVENTIONbalance assessment
Stroke smartphone training
EXPERIMENTALsmartphone balance training
Stroke traditional training
ACTIVE COMPARATORtraditional physical therapy training
Interventions
use smartphone application to training balance
Eligibility Criteria
You may qualify if:
- stroke
- Brunnstrom stage \> 4
- able to walk independently indoors
- able to follow order of the researchers
You may not qualify if:
- have any diseases that may affect balance performance except stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital
Taipei, Neihu District, 11490, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
You-Ruei Hou, Master
National Yang Ming Chiao Tung University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2019
First Posted
July 31, 2019
Study Start
May 23, 2018
Primary Completion
June 30, 2022
Study Completion
August 31, 2023
Last Updated
July 12, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share