Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled TrialNCT03086889
Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke
A study testing immersion virtual reality (VR)-based rehabilitation and traditional rehabilitation training in people with Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial
- What is being tested?
- immersion virtual reality (VR)-based rehabilitation and traditional rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2017to 1 Jan 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having had an ischemic stroke in the first time
- age 30 to 80 years old
- first stroke within 2 month
- GCS score >8
- the upper-limb function BrunnstromⅡ、Ⅲ
Who cannot join
- hemorrhage or transient ischemic attack(TIA)
- important organs such as heart, lung, liver, kidney function decline or failure
- previous history of brain neurosurgery or epilepsy
- had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators
- with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke：Study Protocol of a Randomized Clinical Trial
The investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. The control group will receive for traditional rehabilitation training for 3 weeks. Then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.
- Being tested
- immersion virtual reality (VR)-based rehabilitation, traditional rehabilitation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersion virtual reality (VR)-based rehabilitationOther
Intervention group received VR-based rehabilitation,including Virtual kitchen and so on.The patients took part in the exercise program for 30 minutes each day, five times per week, for 3 weeks. All subjects received physiotherapy, which accounts for an average of 30 minutes of physiotherapy per day on tolerance.
traditional rehabilitation trainingOther
The traditional rehabilitation training included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 60 minutes each day, five times per week, for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks. Receives: Other: immersion virtual reality (VR)-based rehabilitation |
| The control group | Other | The control group will receive for traditional rehabilitation training for 3 weeks. Receives: Other: traditional rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Arm Movement Ability at 3 months
The Fugl-Meyer Assessment
Measured: Baseline and at 3 months
Secondary outcomes (3)
Change from Baseline Activities of Daily Living (ADL) at 3 months
The Barthel index
Measured: Baseline and at 3 months
Change from Baseline Cognitive Function at 3 months
the Korea-MiniMental Status Evaluation (K-MMSE)
Measured: Baseline and at 3 months
Change from Baseline Cortical and Subcortical Activation Patterns at 3 months
Functional MRI (fMRI)
Measured: Baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start20 Apr 2017
- Primary completion1 May 2022
- Study completion1 Jan 2023
Why it stopped: The trials were stopped after recruiting 60% of the planned sample after a median of 3 months follow-up and one interim analysis. The immersive virtual reality based training has proven to work.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled TrialStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song-he Jiang, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086889
- Sponsor's protocol ID
- KFYXK001
- Status last verified
- Jan 2023
- First submitted
- 9 Mar 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang Q, Jiang X, Jin Y, Wu B, Vigotsky AD, Fan L, Gu P, Tu W, Huang L, Jiang S. Immersive virtual reality-based rehabilitation for subacute stroke: a randomized controlled trial. J Neurol. 2024 Mar;271(3):1256-1266. doi: 10.1007/s00415-023-12060-y. Epub 2023 Nov 10.
PubMed 37947856Huang Q, Wu W, Chen X, Wu B, Wu L, Huang X, Jiang S, Huang L. Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial. Trials. 2019 Feb 6;20(1):104. doi: 10.1186/s13063-019-3177-y.
PubMed 30728055
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke：Study Protocol of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03086889
- Acronym / sponsor ID
- KFYXK001
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trials were stopped after recruiting 60% of the planned sample after a median of 3 months follow-up and one interim analysis. The immersive virtual reality based training has proven to work.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 22 Mar 2017 (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 investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. The control group will receive for traditional rehabilitation training for 3 weeks. Then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Other: immersion virtual reality (VR)-based rehabilitationThe intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks. |
| The control group | Other | Other: traditional rehabilitation trainingThe control group will receive for traditional rehabilitation training for 3 weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- having had an ischemic stroke in the first time
- age 30 to 80 years old
- first stroke within 2 month
- GCS score >8
- the upper-limb function BrunnstromⅡ、Ⅲ
Key exclusion criteria (5 listed)
- hemorrhage or transient ischemic attack(TIA)
- important organs such as heart, lung, liver, kidney function decline or failure
- previous history of brain neurosurgery or epilepsy
- had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators
- with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning
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 |
|---|---|---|
| immersion virtual reality (VR)-based rehabilitationIntervention group received VR-based rehabilitation,including Virtual kitchen and so on.The patients took part in the exercise program for 30 minutes each day, five times per week, for 3 weeks. All subjects received physiotherapy, which accounts for an average of 30 minutes of physiotherapy per day on tolerance. | Other | The intervention group |
| traditional rehabilitation trainingThe traditional rehabilitation training included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 60 minutes each day, five times per week, for 3 weeks. | Other | The control group |
Primary outcome
Change from Baseline Arm Movement Ability at 3 months
Time frame: Baseline and at 3 months
The Fugl-Meyer Assessment
3 secondary outcomes
Change from Baseline Activities of Daily Living (ADL) at 3 months
Time frame: Baseline and at 3 months
Change from Baseline Cognitive Function at 3 months
Time frame: Baseline and at 3 months
Change from Baseline Cortical and Subcortical Activation Patterns at 3 months
Time frame: Baseline and at 3 months
Results and safety
The study was stopped early (reason given: The trials were stopped after recruiting 60% of the planned sample after a median of 3 months follow-up and one interim analysis. The immersive virtual reality based training has proven to work.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 37947856Huang Q, Jiang X, Jin Y, Wu B, Vigotsky AD, Fan L, Gu P, Tu W, Huang L, Jiang S. Immersive virtual reality-based rehabilitation for subacute stroke: a randomized controlled trial. J Neurol. 2024 Mar;271(3):1256-1266. doi: 10.1007/s00415-023-12060-y. Epub 2023 Nov 10.
- Derived from this study: PubMed 30728055Huang Q, Wu W, Chen X, Wu B, Wu L, Huang X, Jiang S, Huang L. Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial. Trials. 2019 Feb 6;20(1):104. doi: 10.1186/s13063-019-3177-y.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immersion virtual reality (VR)-based rehabilitation and traditional rehabilitation training in people with Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 5 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: stopped early, as of the sponsor's last update on 18 Jan 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 China. 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 was stopped early (reason given: The trials were stopped after recruiting 60% of the planned sample after a median of 3 months follow-up and one interim analysis. The immersive virtual reality based training has proven to work.). Results are not available in the source record.
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?
Change from Baseline Arm Movement Ability at 3 months (time frame: Baseline and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086889, which also lists 2 linked publications.
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 18 Jan 2023.