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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The first onset of stroke is diagnosed and confirmed according to the requirements of stroke

The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than 34.

18-85 years of age.

Able to walk with minor assistance

Disqualifiers

Severe visual or hearing impairments.

Pregnant or breastfeeding women.

Patients with unrepaired cranial bone flaps or metallic implants following brain surgery.

Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • multi-sensory stimulation immersive VR+ treadmill training

    Device

    Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group

  • treadmill training

    Device

    Only treadmill training in treadmill training group

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VR+treadmill training groupExperimental treatment 1 intervention
Group B: treadmill training groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fugl-Meyer Assessment- Lower Extremity

The Fugl-Meyer Assessment of Motor Recovery after Stroke - Lower Extremity (FMA-LE) evaluates lower extremity motor impairment through 17 items assessing reflexes, synergy patterns, and coordination. Each item is scored 0-2 (total range 0-34), with higher scores indicating better motor function. The total is the sum of all items, including motor (0-30) and coordination (0-4) subcomponents.

Time frame
30 days (Adjust according to the actual situation of patients)

Secondary outcomes

1

Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2)

Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) measures cortical activation in the supplementary motor area via oxygenated hemoglobin concentration changes. Values are reported as changes from baseline in mmol/L, with increases indicating greater neural activity during motor tasks.

Time frame
30 days (Adjust according to the actual situation of patients)
2

Berg balance scale

Berg Balance Scale (BBS) is a 14-item performance-based measure that assesses static and dynamic balance abilities in older adults or individuals with impaired balance function. Each item is rated on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (able to perform independently), yielding a total score range of 0 to 56, with higher scores indicating better balance and lower fall risk. The total score is calculated by summing all 14 individual item scores, and it is commonly used to evaluate balance impairment and predict fall risk in clinical populations.

Time frame
30 days (Adjust according to the actual situation of patients)
3

3D Gait Analysis - Affected Side Step Width

3D Gait Analysis - Affected Side Step Width: This parameter measures the lateral distance between the two feet during walking, derived from three-dimensional motion analysis, focusing on the affected side. Units are centimeters (cm), with typical values ranging from approximately 5 to 20 cm depending on individual factors. Higher values represent wider step width, which may indicate balance deficits or compensatory strategies; lower values may also reflect instability. The clinical interpretation of better or worse outcomes is context-dependent.

Time frame
30 days (Adjust according to the actual situation of patients)
4

Montreal Cognitive Assessment(MoCA)

Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment, evaluating visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It comprises 30 items with a total score range of 0 to 30, where higher scores indicate better cognitive function (≥26 considered normal). The total is the sum of all subdomain scores.

Time frame
30 days (Adjust according to the actual situation of patients)

Other outcomes

1

Fall incidents

Safety assessment

Time frame
30 days (Adjust according to the actual situation of patients)
2

Dizzy incidents

Safety assessment

Time frame
30 days (Adjust according to the actual situation of patients)

Sponsors and contacts

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