Smartphone-based Balance Assessment System for Chronic Stroke

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: smartphone-based balance training system

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: You-Ruei Hou, Master; Phone Number: +886-908-127-775; Email: yrhou.pt@gmail.com
• Study Contact Backup: Name: Wen-Hsu Sung, Doctor; Phone Number: 5927 +886-2-2826-7000; Email: wenhsusung@gmail.com

Study Locations

• Taiwan
  • Neihu District
    • Taipei, Neihu District, Taiwan, 11490
      • Recruiting
      • Tri-Service General Hospital
      • Contact: You-Ruei Hou, Master; Phone Number: +886-908-127-775; Email: yrhou.pt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Healthy Adult; balance assessment
NO_INTERVENTION: Stroke; balance assessment
EXPERIMENTAL: Stroke smartphone training; smartphone balance training	Device: smartphone-based balance training system; use smartphone application to training balance; Other Names: traditional physical therapy
ACTIVE_COMPARATOR: Stroke traditional training; traditional physical therapy training	Device: smartphone-based balance training system; use smartphone application to training balance; Other Names: traditional physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Tri-Service General Hospital
• Investigators: Study Chair: You-Ruei Hou, Master, National Yang Ming University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2018
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (ACTUAL): July 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1-107-05-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No