Clinical trial NCT06275516: Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.
Official title: A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer scale
timeFrame: 30 days (Adjust according to the actual situation of patients)
measure: Berg balance scale
timeFrame: 30 days (Adjust according to the actual situation of patients)
measure: three-dimensional gait detection
timeFrame: 30 days (Adjust according to the actual situation of patients)
measure: Fall incidents
timeFrame: 30 days (Adjust according to the actual situation of patients)
measure: Dizzy incidents
timeFrame: 30 days (Adjust according to the actual situation of patients)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dingqun Bai
role: STUDY_CHAIR
References: