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Smartphone-based Balance Assessment System for Chronic Stroke

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ClinicalTrials.gov Identifier: NCT04040101
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by (Responsible Party):
National Yang Ming University

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.


Condition or disease Intervention/treatment Phase
Stroke Device: smartphone-based balance training system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Development of a Smartphone-based Balance Assessment System for Subjects With Chronic Stroke
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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 Name: 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 Name: traditional physical therapy




Primary Outcome Measures :
  1. Balance performance assessed by smartphone-based balance test [ Time Frame: 4 weeks ]
    The data of smartphone built-in accelerometer and gyroscope will be measured and calculated

  2. Balance performance assessed by force plates [ Time Frame: 4 weeks ]
    The movement of center of pressure (COP) will be measured and calculated

  3. Balance performance assessed by Berg balance scale [ Time Frame: 4 weeks ]
    The score of Berg balance scale will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040101


Contacts
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Contact: You-Ruei Hou, Master +886-908-127-775 yrhou.pt@gmail.com
Contact: Wen-Hsu Sung, Doctor +886-2-2826-7000 ext 5927 wenhsusung@gmail.com

Locations
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Taiwan
Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 11490
Contact: You-Ruei Hou, Master    +886-908-127-775    yrhou.pt@gmail.com   
Sponsors and Collaborators
National Yang Ming University
Tri-Service General Hospital
Investigators
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Study Chair: You-Ruei Hou, Master National Yang Ming University

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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT04040101     History of Changes
Other Study ID Numbers: 1-107-05-048
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases