Hemiparesis as Late Effect of Cerebrovascular DiseaseNCT04360460
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
A study testing Immersive virtual reality + related functional translation into real-life and Immersive virtual reality + non-related translation into real-life in people with Hemiparesis as Late Effect of Cerebrovascular Disease, run by Loma Linda University at 1 site in United States.
Trial summary
This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemiparesis as Late Effect of Cerebrovascular Disease
- What is being tested?
- Immersive virtual reality + related functional translation into real-life and Immersive virtual reality + non-related translation into real-life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 18 Aug 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years old
- Hospitalized at Loma Linda East Campus Rehabilitation Hospital
- First time stroke patient
- Upper limb hemiparesis
- English-speaking
- Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb
Who cannot join
- Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
- Patients with hemicraniectomy
- Current uncontrolled seizures
- Active infections requiring contact precautions
- Cognitively unable to participate
- Vision loss limiting ability to participate with VR therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Tom and Vi Zapara Rehabilitation Pavilion
Loma Linda, California, 92354
About this study
This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.
Read the detailed description
Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.
- Being tested
- Immersive virtual reality + related functional translation into real-life, Immersive virtual reality + non-related translation into real-life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality + related functional translation into real-lifeOther
The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.
Immersive virtual reality + non-related translation into real-lifeOther
The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies Receives: Other: Immersive virtual reality + related functional translation into real-life |
| Control | Active comparator | Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies Receives: Other: Immersive virtual reality + non-related translation into real-life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log
ADL Self-Reported Questionnaire
Amount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke).
How well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal).
Measured: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary outcomes (4)
Modified Barthel's Index
Quality of Life Self-Reported Questionnaire
80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent <20 Totally dependent
Measured: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Fugl-Meyer Upper Extremity Assessment
Post-stroke upper extremity assessment
Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79
Measured: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Montreal Cognitive Assessment
Cognitive Assessment
No cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20
Measured: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Functional Independence Measurement Score
Functional evaluation
7 - complete independence 6 - modified indepdendence 5 - supervision/Setup 4 - minimal contact assistance 3 - moderate assistance 2 - maximal assistance
1 - total assistance 0 - activity does not occur
Measured: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start3 Dec 2020
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis as Late Effect of Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Tarver, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360460
- Sponsor's protocol ID
- 5200147
- Status last verified
- May 2023
- First submitted
- 16 Apr 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
- ClinicalTrials.gov ID
- NCT04360460
- Acronym / sponsor ID
- 5200147
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 24 Apr 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.
This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.
Detailed description
Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Immersive virtual reality + related functional translation into real-lifeVirtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies |
| Control | Active comparator | Other: Immersive virtual reality + non-related translation into real-lifeVirtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-90 years old
- Hospitalized at Loma Linda East Campus Rehabilitation Hospital
- First time stroke patient
- Upper limb hemiparesis
- English-speaking
Key exclusion criteria (6 listed)
- Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
- Patients with hemicraniectomy
- Current uncontrolled seizures
- Active infections requiring contact precautions
- Cognitively unable to participate
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 |
|---|---|---|
| Immersive virtual reality + related functional translation into real-lifeThe experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks. | Other | Experimental |
| Immersive virtual reality + non-related translation into real-lifeThe control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks. | Other | Control |
Primary outcome
Motor Activity Log
Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
ADL Self-Reported Questionnaire Amount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke). How well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal).
4 secondary outcomes
Modified Barthel's Index
Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Fugl-Meyer Upper Extremity Assessment
Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Montreal Cognitive Assessment
Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Functional Independence Measurement Score
Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis as Late Effect of Cerebrovascular Disease
Active, not recruiting
NuroSleeve Powered Brace & Stimulation System to Restore Arm Function
Neurologic Diseases, Hemiparesis
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.
Christopher Tarver, MD principal investigator
Loma Linda 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 Immersive virtual reality + related functional translation into real-life and Immersive virtual reality + non-related translation into real-life in people with Hemiparesis as Late Effect of Cerebrovascular Disease, run by Loma Linda University at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 23 May 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Activity Log (time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)). 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 23 May 2023.