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

Dingqun Bai

Status: Not yet enrolling

Conditions: Stroke; Cognitive Decline

Treatments: Device: immersive VR pathfinding training; Other: Occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06704360

20241120

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment
2. 18-85 years old
3. Be able to follow instructions to complete the test
4. Can tolerate the rehabilitation training of this experiment
5. First stroke
6. Patients who signed informed consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

VR group (virtual reality cognitive training group)

Experimental group

Description:

Immersive VR cognitive training with suitable training intensity.

Treatment:

Device: immersive VR pathfinding training

OT group (occupational therapy group)

Active Comparator group

Description:

Conventional cognitive training (occupational therapy) with suitable training intensity.

Treatment:

Other: Occupational therapy