StrokeNCT02029664
Gait Control of Stroke Patients Using Visual Feedback
A study testing Visual distortion increment based on the gait pattern in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the possibility of gait pattern change via visual feedback among patients with stroke. Also, the optimal visual feedback would be chosen from this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Visual distortion increment based on the gait pattern
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemiplegic stroke patients >= 18 years old
- Functional Ambulation Category >=3
- Cognitively intact enough to follow the study protocol
- Adults without any gait problem
Who cannot join
- Quadriplegic stroke patients
- Orthopedic problems to affect gait
- Underlying other neurological or psychological disorders
- Spasticity or contracture which impede the gait.
- Uncontrolled medical problems
- Pregnant.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, Seoul, 142884
Joon-Ho Shin, MS, 82-10-3168-7043, asfreelyas@gmail.com
About this study
The purpose of this study is to determine the possibility of gait pattern change via visual feedback among patients with stroke. Also, the optimal visual feedback would be chosen from this study.
- Conditions
- Stroke
- Being tested
- Visual distortion increment based on the gait pattern
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual distortion increment based on the gait patternDevice
| Study group | Role | What they receive |
|---|---|---|
| Visual feedback distortion | Experimental | Visual distortion increment based on the gait pattern Receives: Device: Visual distortion increment based on the gait pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length symmetry
Step length symmetry during treadmill gait. When the participants walk on the treadmill, the walk symmetry was calculated from the sensor attached to them.
During the whole period of treadmill gait, step length asymmetry will be recorded.
Measured: Participants will be followed for the duration of treadmill gait, an expected average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029664
- Sponsor's protocol ID
- NRC-2013-04-037
- Status last verified
- Oct 2016
- First submitted
- 28 Dec 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Control of Stroke Patients Using Visual Feedback
- ClinicalTrials.gov ID
- NCT02029664
- Acronym / sponsor ID
- NRC-2013-04-037
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 8 Jan 2014 (estimated)
- 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.
The purpose of this study is to determine the possibility of gait pattern change via visual feedback among patients with stroke. Also, the optimal visual feedback would be chosen from this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual feedback distortion | Experimental | Device: Visual distortion increment based on the gait patternVisual distortion increment based on the gait pattern |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hemiplegic stroke patients >= 18 years old
- Functional Ambulation Category >=3
- Cognitively intact enough to follow the study protocol
- Adults without any gait problem
Key exclusion criteria (6 listed)
- Quadriplegic stroke patients
- Orthopedic problems to affect gait
- Underlying other neurological or psychological disorders
- Spasticity or contracture which impede the gait.
- Uncontrolled medical problems
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 |
|---|---|---|
| Visual distortion increment based on the gait pattern | Device | Visual feedback distortion |
Primary outcome
Step length symmetry
Time frame: Participants will be followed for the duration of treadmill gait, an expected average of 15 minutes
Step length symmetry during treadmill gait. When the participants walk on the treadmill, the walk symmetry was calculated from the sensor attached to them. During the whole period of treadmill gait, step length asymmetry will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Related InfoLink provided by the sponsor.
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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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.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual distortion increment based on the gait pattern in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
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 6 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 25 Oct 2016. 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 South Korea. 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 Joon-Ho Shin, MS (82-10-3168-7043, asfreelyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length symmetry (time frame: Participants will be followed for the duration of treadmill gait, an expected average of 15 minutes). 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 25 Oct 2016.