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StrokeNCT04040101

Smartphone-based Balance Assessment System for Chronic Stroke

A study testing smartphone-based balance training system in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
smartphone-based balance training system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteTaiwan
Study dates
23 May 2018to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • stroke
  • Brunnstrom stage > 4
  • able to walk independently indoors
  • able to follow order of the researchers

Who cannot join

  • have any diseases that may affect balance performance except stroke

Trial locations and contacts

1 site in 1 country.

You-Ruei Hou, Master contact

+886-908-127-775

yrhou.pt@gmail.com

Taiwan1 site, 1 recruiting
  • Tri-Service General Hospital

    Taipei, Neihu District, 11490

    You-Ruei Hou, Master, +886-908-127-775, yrhou.pt@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read more

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.

Conditions
Stroke
Being tested
smartphone-based balance training system
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smartphone-based balance training systemDevice

    Also called traditional physical therapy

    use smartphone application to training balance

Study groups in NCT04040101
Study groupRoleWhat they receive
Healthy AdultNo interventionbalance assessment
StrokeNo interventionbalance assessment
Stroke smartphone trainingExperimentalsmartphone balance training
Receives: Device: smartphone-based balance training system
Stroke traditional trainingActive comparatortraditional physical therapy training
Receives: Device: smartphone-based balance training system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance performance assessed by smartphone-based balance test

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

    Measured: 4 weeks

  2. Balance performance assessed by force plates

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

    Measured: 4 weeks

  3. Balance performance assessed by Berg balance scale

    The score of Berg balance scale will be measured

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2019
  2. Study start23 May 2018
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04040101
Sponsor's protocol ID
1-107-05-048
Status last verified
Apr 2022
First submitted
14 Jul 2019
Last updated
12 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing smartphone-based balance training system in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact You-Ruei Hou, Master (+886-908-127-775, yrhou.pt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance performance assessed by smartphone-based balance test (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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Clinical Trial NCT04040101 | AzTrials