Smartphone-based Balance Assessment System for Chronic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04040101
• Other study ID #: 1-107-05-048
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2022
• Source: National Yang Ming University
• Contact: You-Ruei Hou, Master
• Phone: +886-908-127-775
• Email: yrhou.pt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• smartphone-based balance training system
use smartphone application to training balance

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei	Neihu District

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance performance assessed by smartphone-based balance test	The data of smartphone built-in accelerometer and gyroscope will be measured and calculated	4 weeks
Primary	Balance performance assessed by force plates	The movement of center of pressure (COP) will be measured and calculated	4 weeks
Primary	Balance performance assessed by Berg balance scale	The score of Berg balance scale will be measured	4 weeks