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.
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.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Neihu District, 11490
You-Ruei Hou, Master, +886-908-127-775, yrhou.pt@gmail.com
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 group | Role | What they receive |
|---|---|---|
| Healthy Adult | No intervention | balance assessment |
| Stroke | No intervention | balance assessment |
| Stroke smartphone training | Experimental | smartphone balance training Receives: Device: smartphone-based balance training system |
| Stroke traditional training | Active comparator | traditional 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.
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
Balance performance assessed by force plates
The movement of center of pressure (COP) will be measured and calculated
Measured: 4 weeks
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.
- First posted31 Jul 2019
- Study start23 May 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- You-Ruei Hou, Master, Study chair, National Yang Ming Chiao Tung University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Smartphone-based Balance Assessment System for Subjects With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04040101
- Acronym / sponsor ID
- 1-107-05-048
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult | No intervention | –balance assessment |
| Stroke | No intervention | –balance assessment |
| Stroke smartphone training | Experimental | Device: smartphone-based balance training systemsmartphone balance training |
| Stroke traditional training | Active comparator | Device: smartphone-based balance training systemtraditional physical therapy training |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stroke
- Brunnstrom stage > 4
- able to walk independently indoors
- able to follow order of the researchers
Key exclusion criteria (1 listed)
- have any diseases that may affect balance performance except stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smartphone-based balance training systemAlso: traditional physical therapyuse smartphone application to training balance | Device | Stroke smartphone training, Stroke traditional training |
Primary outcome
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
Balance performance assessed by force plates
Time frame: 4 weeks
The movement of center of pressure (COP) will be measured and calculated
Balance performance assessed by Berg balance scale
Time frame: 4 weeks
The score of Berg balance scale will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
You-Ruei Hou, Master study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
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.