StrokeNCT04103957
Exploring the Effect of Visual Feedback on Motion Trajectory in a Virtual Reality Environment.
An observational study of Stroke and Control, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The rehabilitation intensity and frequency of upper extremities of stroke patients is insufficient. Virtual reality technique may solved this problem. The investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and to explore the effect of visual feedback on… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2020to Dec 2021
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients Healthy people
Who may be able to join
None listed.
Who cannot join
- Crucial organ failure, including heart, lung, liver, and kidney.
- Brain operation and epilepsy.
- Severe metal illness and aphasia, so cannot follow order
- Feel uncomfortable while using virtual reality.
- Crucial eye problems, including color-blind, weak color, cataract, glaucoma, etc.
- Mental illness, neuro-musculoskeletal system lesions, vertigo, claustrophobic.
Show all 14Show fewer
- Illness and pain to affect upper extremities movement.
- Healthy people Inclusion criteria
- Age:20~100y/o.
- No pain to affect upper extremities movement.
- Feel uncomfortable while using virtual reality.
- Crucial eye problems, including color-blind, weak color, cataract, glaucoma, etc.
- Cognition impairment, history of mental illness, neuro-musculoskeletal system lesions, vertigo, claustrophobic.
- Epilepsy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng Dist, 100
Tzu Ling Tai, MAMS, 02-23123456 ext. 67741, tzulingtai@gmail.com
Huey Wen Liang, PhD, 02-23123456 ext. 66697, lianghw@ntu.edu.tw
About this study
The rehabilitation intensity and frequency of upper extremities of stroke patients is insufficient. Virtual reality technique may solved this problem. The investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and to explore the effect of visual feedback on motion trajectory in a virtual reality environment.
Read the detailed description
How to increase the rehabilitation intensity in the critical rehabilitation window for stroke patients (half year since onset) was very important. The training intensity and frequency of upper extremities is insufficient. The proprioceptive neuromuscular facilitation (PNF) movements of upper extremities are applied to all daily upper extremities movement. The goals of this study are that the investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and the investigators want to explore the effect of visual feedback on motion trajectory in a virtual reality environment. The investigators will record the motion patterns, motion trajectory and the deviation of position and angle comparing to the normal PNF movement pattern to analyze the motion accuracy.
- Keywords
- Virtual reality
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion accuracy
Record the motion patterns, motion trajectory and the deviation of position and angle comparing to the normal PNF movement pattern to analyze the motion accuracy
Measured: during the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Apr 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu Ling Tai, MAMS, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103957
- Sponsor's protocol ID
- 201907130RINB
- Status last verified
- May 2021
- First submitted
- 24 Sep 2019
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Visual Feedback on Motion Trajectory in a Virtual Reality Environment.
- ClinicalTrials.gov ID
- NCT04103957
- Acronym / sponsor ID
- 201907130RINB
- Keywords
- Virtual reality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Sep 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.
The rehabilitation intensity and frequency of upper extremities of stroke patients is insufficient. Virtual reality technique may solved this problem. The investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and to explore the effect of visual feedback on motion trajectory in a virtual reality environment.
Detailed description
How to increase the rehabilitation intensity in the critical rehabilitation window for stroke patients (half year since onset) was very important. The training intensity and frequency of upper extremities is insufficient. The proprioceptive neuromuscular facilitation (PNF) movements of upper extremities are applied to all daily upper extremities movement. The goals of this study are that the investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and the investigators want to explore the effect of visual feedback on motion trajectory in a virtual reality environment. The investigators will record the motion patterns, motion trajectory and the deviation of position and angle comparing to the normal PNF movement pattern to analyze the motion accuracy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients Healthy people
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Crucial organ failure, including heart, lung, liver, and kidney.
- Brain operation and epilepsy.
- Severe metal illness and aphasia, so cannot follow order
- Feel uncomfortable while using virtual reality.
- Crucial eye problems, including color-blind, weak color, cataract, glaucoma, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motion accuracy
Time frame: during the experiment
Record the motion patterns, motion trajectory and the deviation of position and angle comparing to the normal PNF movement pattern to analyze the motion accuracy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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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.
Tzu Ling Tai, MAMS principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Control, run by National Taiwan University Hospital 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 0 inclusion and 14 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 26 May 2021. 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 Tzu Ling Tai, MAMS (02-23123456 ext. 67741, tzulingtai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion accuracy (time frame: during the experiment). 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 26 May 2021.