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Not yet recruiting NCT06704360

Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment

No phase Interventional Stroke Cognitive Decline

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: immersive VR pathfinding training, Occupational therapy.
Who it may be relevant to
Registry conditions: Stroke, Cognitive Decline. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment

Overview

This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.

Detailed description

This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.

In the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.

In the baseline assessment period and endpoint assessment period, cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).

In the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions.

Interventions

  • Device immersive VR pathfinding training
    Pathfinding training with immersive VR.
  • Other Occupational therapy
    Only receive conventional cognitive training group

Primary outcome measures

  • Mental State Examination Scale (MMSE) [Time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training]
  • Montreal Cognitive Assessment (MoCA) [Time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training]
  • Brain functional activation (fNIRS) [Time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training]

Eligibility criteria

Inclusion criteria

  • Diagnosis of stroke by neuroimaging (CT or MRI) assessment
  • 18-85 years old
  • Be able to follow instructions to complete the test
  • Can tolerate the rehabilitation training of this experiment
  • First stroke
  • Patients who signed informed consent

Exclusion criteria

  • The test could not be tolerated due to organic disease
  • There is a serious mental illness resulting in inability to cooperate with or tolerate this test
  • is participating in another clinical trial involving an investigational drug or physical therapy
  • Patients who have not signed informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06704360 · 20241120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗