Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: treadmill training; Device: multi-sensory stimulation immersive VR+ treadmill training

• Registration Number: NCT06275516
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.

Detailed Description

This was single-blind randomized controlled intervention study. Each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period.

The screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent.

Baseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, Fugl-Meyer scale, Berg balance scale); cognitive function related scale assessment \[Brief Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test, Shape connection test A.B, standardized digital modal experiment, auditory word Learning Test\], emotional correlation scale assessment (Hamilton Depression Scale, Hamilton Anxiety Scale), and activity of daily living scale ADL scale. Meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fNIRs tests and fMRI) were synchronously completed.

The intervention period included multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).

Preliminary validation of effectiveness assessment includes Fugl-Meyer scale, Berg balance scale, and three-dimensional gait detection. Preliminary validation of the safety assessment includes fall and dizzy incidents.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-17
• Last Update Submitted: 2024-02-17
• Study Start: 2024-02-20
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-06-20
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment
2. 18-85 years old
3. Be able to walk with minor assistance
4. Can tolerate the rehabilitation training of this experiment
5. First stroke
6. Be able to follow instructions to complete the test
7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treadmill training group	treadmill training	Only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
VR+treadmill training group	multi-sensory stimulation immersive VR+ treadmill training	Multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).

Primary Outcome Measures

Name	Time	Method
Berg balance scale	30 days (Adjust according to the actual situation of patients)	Balance function evaluation
three-dimensional gait detection	30 days (Adjust according to the actual situation of patients)	Quantitative motor function assessment
Fugl-Meyer scale	30 days (Adjust according to the actual situation of patients)	Motor function assessment
Fall incidents	30 days (Adjust according to the actual situation of patients)	Safety assessment
Dizzy incidents	30 days (Adjust according to the actual situation of patients)	Safety assessment