Early Rehab With VR for First-time Acute Stroke

National Defense Medical Center, Taiwan

Status: Completed

Conditions: Stroke, Acute; Acute Ischemic Stroke

Treatments: Behavioral: early rehabilitation; Behavioral: virtual reality training

Study type: Interventional

Funder types: Other

Identifiers

NCT05929742

001-VR

Details and patient eligibility

About

The goal of this clinical trial is to confirm the efficacy and feasibility of early rehabilitation combined with virtual reality training in patients following first-time acute stroke. The main questions it aims to answer are:

• The impact of virtual reality training on muscle strength;
• The impact of virtual reality training on functional recovery;
• The impact of virtual reality training on mood state.

Researchers will compare the experimental group, which received early rehabilitation combined with VR training, and the comparison group, which received only early rehabilitation, to see if VR training has clinical benefits when provided alongside early rehabilitation during hospitalization.

Full description

Early rehabilitation has been shown to enhance outcomes for patients with first-time acute stroke. However, whether the addition of virtual reality (VR) training could further improve muscle strength, functional recovery, and mood state for these patients is unknown. Therefore, this study aimed to investigate the effectiveness of early rehabilitation combined with VR training in patients following first-time acute stroke. Patients with acute ischemic stroke will be selected and randomly assigned with a 1:1 randomization ratio to either the experimental group or the comparison group. Both groups received early rehabilitation, and the experimental group received extra VR training starting 24 hours to 3 days poststroke during the stay in the hospital. Muscle strength, functional status, and mood state will be collected before and after the intervention.

Enrollment: 38 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• first-time acute infarction (ischemic stroke);
• admission to the hospital within three days of stroke onset;
• able to communicate with verbal or nonverbal methods and understand Mandarin;
• had a disability that ranged from minimal to moderately severe disability and evaluated as 1-4 scores by the modified Rankin Scale (mRS);
• agree to be randomized.

Exclusion criteria

• diagnosis of global aphasia, transient ischemic attack, visual or auditory impairment;
• mRS over 5 (severe disability: requires constant nursing care and attention, bedridden, incontinent);
• a history of cancer, end-stage renal disease with dialysis, dementia, mental health disorders (particularly major depression), based on both of medical records and assessments from the neurologist;
• being unable to participate due to other comorbid neurological and musculoskeletal conditions that produce moderate-to-severe physical disability;
• prolonged stay in hospital for over three weeks due to other medical diseases (e.g., myocardial infarction, septic shock, cancer) after admission or length of stay in hospital less than one week due to a decline to treatment and transferred to another hospital for further confirmation of diagnosis and other complementary or alternative therapies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

experimental group

Experimental group

Description:

received early rehabilitation combined with VR training

Treatment:

Behavioral: early rehabilitation

Behavioral: virtual reality training

comparison group

Active Comparator group

Description:

received only early rehabilitation

Treatment:

Behavioral: early rehabilitation