Spatial PerceptionNCT04436237
Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients
A study testing Virtual reality foot placement training in people with Spatial Perception and Stroke, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine if a virtual reality training of foot placement with or without visual cues about the location of the foot in the environment would improve locomotion-related function in persons in the chronic stage of stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spatial Perception, Stroke, Virtual Reality
- What is being tested?
- Virtual reality foot placement training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2019to 31 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first time unilateral stroke and onset over 6 months
- able to independent walking with or without aids over 10 meters
- Mini-Mental State Examination (MMSE) score above 24
- orientation intake, able to identify right and left
- normal or corrected-to-normal vision, able to see the 2 cm diameter circle on the floor while standing
Who cannot join
- gait nearly normal
- had other neurological and musculoskeletal disease which can affect walking ability
- hemineglect
- use virtual reality device will severely discomfort, such as headaches, blurred vision, vertigo or vomiting
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, 701
Sang-I Lin, PhD, +886-6-235-3535 ext. 5020, lin31@mail.ncku.edu.tw
About this study
The purpose of this study is to determine if a virtual reality training of foot placement with or without visual cues about the location of the foot in the environment would improve locomotion-related function in persons in the chronic stage of stroke. Participants were randomly assigned to receive twice per week, for a total of 2 weeks' training with visual cues (control group) or without (experimental group). It was hypothesized that the experimental group would be able to place the foot closer to the target when stepping and have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary results support the hypothesis. This project is still ongoing.
- Conditions
- Spatial Perception, Stroke, Virtual Reality, Exercise Training, Exproprioception
- Being tested
- Virtual reality foot placement training
- Medical subject headings
- Orientation, Spatial, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality foot placement trainingOther
The training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training.
| Study group | Role | What they receive |
|---|---|---|
| Non-visual exproprioception training | Experimental | The training requires the participant to place the foot at a target without visual cues of the foot in virtual environment. Receives: Other: Virtual reality foot placement training |
| Visual exproprioception group | Active comparator | The training requires the participant to place the foot at a target with visual cues of the foot in virtual environment. Receives: Other: Virtual reality foot placement training |
What is being measured
The primary outcome is the main question the study is designed to answer.
foot placement accuracy (cm)
The distance between the foot and the target in various stepping tasks
Measured: 2 weeks
gait symmetry
ratio of the two leg step lengths
Measured: 2 weeks
Secondary outcomes (1)
exproprioception (cm)
the error in placing the unaffected foot at a location previously defined by the affected foot
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start26 Aug 2019
- Primary completion10 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial PerceptionStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-I Lin, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436237
- Sponsor's protocol ID
- A-ER-108-183
- Status last verified
- Sep 2021
- First submitted
- 12 Jun 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients
- ClinicalTrials.gov ID
- NCT04436237
- Acronym / sponsor ID
- A-ER-108-183
- Conditions
- Spatial Perception, Stroke, Virtual Reality, Exercise Training, Exproprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Jun 2020 (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 purpose of this study is to determine if a virtual reality training of foot placement with or without visual cues about the location of the foot in the environment would improve locomotion-related function in persons in the chronic stage of stroke. Participants were randomly assigned to receive twice per week, for a total of 2 weeks' training with visual cues (control group) or without (experimental group). It was hypothesized that the experimental group would be able to place the foot closer to the target when stepping and have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary results support the hypothesis. This project is still ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-visual exproprioception training | Experimental | Other: Virtual reality foot placement trainingThe training requires the participant to place the foot at a target without visual cues of the foot in virtual environment. |
| Visual exproprioception group | Active comparator | Other: Virtual reality foot placement trainingThe training requires the participant to place the foot at a target with visual cues of the foot in virtual environment. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- first time unilateral stroke and onset over 6 months
- able to independent walking with or without aids over 10 meters
- Mini-Mental State Examination (MMSE) score above 24
- orientation intake, able to identify right and left
- normal or corrected-to-normal vision, able to see the 2 cm diameter circle on the floor while standing
Key exclusion criteria (4 listed)
- gait nearly normal
- had other neurological and musculoskeletal disease which can affect walking ability
- hemineglect
- use virtual reality device will severely discomfort, such as headaches, blurred vision, vertigo or vomiting
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 |
|---|---|---|
| Virtual reality foot placement trainingThe training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training. | Other | Non-visual exproprioception training, Visual exproprioception group |
Primary outcome
foot placement accuracy (cm)
Time frame: 2 weeks
The distance between the foot and the target in various stepping tasks
gait symmetry
Time frame: 2 weeks
ratio of the two leg step lengths
1 secondary outcome
exproprioception (cm)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality foot placement training in people with Spatial Perception and Stroke, run by National Cheng Kung 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 5 inclusion and 4 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 5 Sep 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 Sang-I Lin, PhD (+88662353535 ext. 5020, lin31@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
foot placement accuracy (cm) (time frame: 2 weeks). The study lists 2 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 5 Sep 2021.