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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intervention group | Experimental | The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks. |
|
| The control group | Other | The control group will receive for traditional rehabilitation training for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immersion virtual reality (VR)-based rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Arm Movement Ability at 3 months | The Fugl-Meyer Assessment | Baseline and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Activities of Daily Living (ADL) at 3 months | The Barthel index | Baseline and at 3 months |
| Change from Baseline Cognitive Function at 3 months | the Korea-MiniMental Status Evaluation (K-MMSE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Songhe Jiang | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37947856 | Derived | 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. | |
| 30728055 | Derived | Huang 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. |
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|
| traditional rehabilitation training | Other | 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. |
|
| Baseline and at 3 months |
| Change from Baseline Cortical and Subcortical Activation Patterns at 3 months | Functional MRI (fMRI) | Baseline and at 3 months |