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Smartphone-based Balance Assessment System for Chronic Stroke

Development of a Smartphone-based Balance Assessment System for Subjects With Chronic Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04040101
Enrollment
300
Registered
2019-07-31
Start date
2018-05-23
Completion date
2023-08-31
Last updated
2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DEVICEsmartphone-based balance training system

use smartphone application to training balance

Sponsors

Tri-Service General Hospital
CollaboratorOTHER
National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* stroke * Brunnstrom stage \> 4 * able to walk independently indoors * able to follow order of the researchers

Exclusion criteria

* have any diseases that may affect balance performance except stroke

Design outcomes

Primary

MeasureTime frameDescription
Balance performance assessed by smartphone-based balance test4 weeksThe data of smartphone built-in accelerometer and gyroscope will be measured and calculated
Balance performance assessed by force plates4 weeksThe movement of center of pressure (COP) will be measured and calculated
Balance performance assessed by Berg balance scale4 weeksThe score of Berg balance scale will be measured

Countries

Taiwan

Contacts

Primary ContactYou-Ruei Hou, Master
yrhou.pt@gmail.com+886-908-127-775
Backup ContactWen-Hsu Sung, Doctor
wenhsusung@gmail.com+886-2-2826-7000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026