Early Rehab With VR for First-time Acute Stroke

January 15, 2024 updated by: Ta-Chung Chao, National Defense Medical Center, Taiwan

The Efficacy of Early Rehabilitation Combined With Virtual Reality Training in Patients With First-time Acute Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital, National Defense Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
received early rehabilitation combined with VR training
Behavioral: virtual reality training
The experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward.
Behavioral: early rehabilitation
Five 60-minute sessions per week, was prescribed by a rehabilitation physician and performed by physical, occupational, and speech therapists from 3 to 6 days after admission.
Active Comparator: comparison group
received only early rehabilitation
Behavioral: early rehabilitation
Five 60-minute sessions per week, was prescribed by a rehabilitation physician and performed by physical, occupational, and speech therapists from 3 to 6 days after admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength
Time Frame: 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.
through the admission period, an average of 1 month
postural control
Time Frame: 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.
through the admission period, an average of 1 month
activities of daily living
Time Frame: 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.
through the admission period, an average of 1 month
mood state
Time Frame: 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.
through the admission period, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Investigators

  • Study Director: Shang-Lin Chiang, MD, PHD, Tri-Service General Hospital, National Defense Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

August 12, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no intention to share the individual participant data (IPD) collected in this study with other researchers. This decision was influenced by factors such as privacy concerns, confidentiality agreements, legal restrictions, institutional policies that restrict the sharing of sensitive or proprietary data, and ethical considerations to protect the privacy and confidentiality of the participants involved in the study. Therefore, the data will be kept from other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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