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

Stroke Clinical Trial

Official title:

A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275516
• Other study ID #: 2024-208
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: February 2024
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Dingqun Bai
• Phone: 023-89011334
• Email: baidingqun2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• multi-sensory stimulation immersive VR+ treadmill training
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
• treadmill training
Only treadmill training in treadmill training group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Outcome

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