Smartphone-based Balance Assessment System for Chronic Stroke

Sponsor
National Yang Ming University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04040101
Collaborator
Tri-Service General Hospital (Other)
300
1
4
63.3
4.7

Study Details

Study Description

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
  • Device: smartphone-based balance training system
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Balance performance assessed by smartphone-based balance test [4 weeks]

      The data of smartphone built-in accelerometer and gyroscope will be measured and calculated

    2. Balance performance assessed by force plates [4 weeks]

      The movement of center of pressure (COP) will be measured and calculated

    3. Balance performance assessed by Berg balance scale [4 weeks]

      The score of Berg balance scale will be measured

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tri-Service General Hospital Taipei Neihu District Taiwan 11490

    Sponsors and Collaborators

    • National Yang Ming University
    • Tri-Service General Hospital

    Investigators

    • Study Chair: You-Ruei Hou, Master, National Yang Ming University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Yang Ming University
    ClinicalTrials.gov Identifier:
    NCT04040101
    Other Study ID Numbers:
    • 1-107-05-048
    First Posted:
    Jul 31, 2019
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2022