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

NCT ID: NCT06704360

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Stroke; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR group (virtual reality cognitive training group)

Immersive VR cognitive training with suitable training intensity.

Group Type: EXPERIMENTAL

immersive VR pathfinding training

Intervention Type: DEVICE

Pathfinding training with immersive VR.

OT group (occupational therapy group)

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

Group Type: ACTIVE_COMPARATOR

Occupational therapy

Intervention Type: OTHER

Only receive conventional cognitive training group

Interventions

immersive VR pathfinding training

Pathfinding training with immersive VR.

Intervention Type: DEVICE

Occupational therapy

Only receive conventional cognitive training group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dingqun Bai

OTHER

Sponsor Role: lead

Responsible Party

Dingqun Bai

Director of rehabilitation Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dingqun Bai

Role: STUDY_CHAIR

First Affiliated Hospital of Chongqing Medical University

Central Contacts

Dingqun Bai

Role: CONTACT

baidingqun2014@163.com

023-89011334

Defei Chen

Role: CONTACT

2283273437@qq.com

+8615188017034

Other Identifiers

20241120

Identifier Type: -

Identifier Source: org_study_id