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Smartphone-based Balance Assessment System for Chronic Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smartphone-based balance training system
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Active Comparator

Arm Label

Healthy Adult

Stroke

Stroke smartphone training

Stroke traditional training

Arm Description

balance assessment

balance assessment

smartphone balance training

traditional physical therapy training

Outcomes

Primary Outcome Measures

Balance performance assessed by smartphone-based balance test
The data of smartphone built-in accelerometer and gyroscope will be measured and calculated
Balance performance assessed by force plates
The movement of center of pressure (COP) will be measured and calculated
Balance performance assessed by Berg balance scale
The score of Berg balance scale will be measured

Secondary Outcome Measures

Full Information

First Posted
July 14, 2019
Last Updated
July 10, 2022
Sponsor
National Yang Ming University
Collaborators
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04040101
Brief Title
Smartphone-based Balance Assessment System for Chronic Stroke
Official Title
Development of a Smartphone-based Balance Assessment System for Subjects With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Adult
Arm Type
No Intervention
Arm Description
balance assessment
Arm Title
Stroke
Arm Type
No Intervention
Arm Description
balance assessment
Arm Title
Stroke smartphone training
Arm Type
Experimental
Arm Description
smartphone balance training
Arm Title
Stroke traditional training
Arm Type
Active Comparator
Arm Description
traditional physical therapy training
Intervention Type
Device
Intervention Name(s)
smartphone-based balance training system
Other Intervention Name(s)
traditional physical therapy
Intervention Description
use smartphone application to training balance
Primary Outcome Measure Information:
Title
Balance performance assessed by smartphone-based balance test
Description
The data of smartphone built-in accelerometer and gyroscope will be measured and calculated
Time Frame
4 weeks
Title
Balance performance assessed by force plates
Description
The movement of center of pressure (COP) will be measured and calculated
Time Frame
4 weeks
Title
Balance performance assessed by Berg balance scale
Description
The score of Berg balance scale will be measured
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
You-Ruei Hou, Master
Phone
+886-908-127-775
Email
yrhou.pt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Hsu Sung, Doctor
Phone
+886-2-2826-7000
Ext
5927
Email
wenhsusung@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You-Ruei Hou, Master
Organizational Affiliation
National Yang Ming University
Official's Role
Study Chair
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You-Ruei Hou, Master
Phone
+886-908-127-775
Email
yrhou.pt@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Smartphone-based Balance Assessment System for Chronic Stroke

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