Early Rehab With VR for First-time Acute Stroke

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke; Stroke, Acute
• Interventions: Behavioral: virtual reality training; Behavioral: early rehabilitation

• Registration Number: NCT05929742
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-12
• Primary Completion: 2018-08-12
• Study Completion: 2018-12-31
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	early rehabilitation	received early rehabilitation combined with VR training
comparison group	early rehabilitation	received only early rehabilitation
experimental group	virtual reality training	received early rehabilitation combined with VR training

Primary Outcome Measures

Name	Time	Method
activities of daily living	through the admission period, an average of 1 month	The Barthel scale used to assess individuals' performance in activities of daily living has high inter-rater reliability and test-retest reliability as well as high correlations with other measures of physical disability. The scores of the 10-item Barthel scale range from 0-100 with 5-point increments. Patients with higher scores are more independent than those with lower scores in their daily activities.
postural control	through the admission period, an average of 1 month	The Postural Assessment Scale for Stroke (PASS), consisting of two sections with a 4-point scale, with 0 being the lowest level of functionality and 3 the highest, and a total score ranging from 0-36, is a well-validated clinical assessment tool for postural control in patients with stroke during the first three months after stroke.
mood state	through the admission period, an average of 1 month	Mood state was assessed by the Hospital Anxiety and Depression Scale (HADS). This well-validated tool has 14 items (7 items related to anxiety \[HADS-A\] and 7 related to depression \[HADS-D\]). Each item of the HADS is scored from 0-3, and the range is 0-21 for depression and anxiety. Participants with higher scores represent a higher level of depression or anxiety. A cut-off point of 8 has been identified for anxiety or depression.
muscle strength	through the admission period, an average of 1 month	The testing involved assessing the patient's upper and lower limb/extremities muscles against the examiner's resistance and grading the patient's strength on a 0-5 scale, higher scores mean a better outcome.

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei, Taiwan