Smartphone-based Balance Assessment System for Chronic Stroke

NCT ID: NCT04040101

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Healthy Adult

balance assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Stroke

balance assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Stroke smartphone training

smartphone balance training

Group Type EXPERIMENTAL

smartphone-based balance training system

Intervention Type DEVICE

use smartphone application to training balance

Stroke traditional training

traditional physical therapy training

Group Type ACTIVE_COMPARATOR

smartphone-based balance training system

Intervention Type DEVICE

use smartphone application to training balance

Interventions

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smartphone-based balance training system

use smartphone application to training balance

Intervention Type DEVICE

Other Intervention Names

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traditional physical therapy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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You-Ruei Hou, Master

Role: STUDY_CHAIR

National Yang Ming Chiao Tung University

Locations

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Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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You-Ruei Hou, Master

Role: CONTACT

+886-908-127-775

Wen-Hsu Sung, Doctor

Role: CONTACT

+886-2-2826-7000 ext. 5927

Facility Contacts

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You-Ruei Hou, Master

Role: primary

+886-908-127-775

Other Identifiers

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1-107-05-048

Identifier Type: -

Identifier Source: org_study_id

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