Early Rehab With VR for First-time Acute Stroke

NCT05929742 | Completed DMC

• 1 other identifier: 001-VR
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Acute Ischemic Stroke

Keywords

Early rehabilitation; Virtual reality

Outcome Measures

Primary Outcomes (4)

• muscle strength

  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

  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

  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

  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

Study Arms (2)

experimental group

EXPERIMENTAL

received early rehabilitation combined with VR training

Behavioral: virtual reality training; Behavioral: early rehabilitation

comparison group

ACTIVE COMPARATOR

received only early rehabilitation

Behavioral: early rehabilitation

Interventions

virtual reality training BEHAVIORAL

The experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward.

experimental group

early rehabilitation BEHAVIORAL

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.

comparison group; experimental group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

Location

Related Publications (6)

• Khan A, Podlasek A, Somaa F. Virtual reality in post-stroke neurorehabilitation - a systematic review and meta-analysis. Top Stroke Rehabil. 2023 Jan;30(1):53-72. doi: 10.1080/10749357.2021.1990468. Epub 2021 Nov 7.

  PMID: 34747351 BACKGROUND

• Hao J, Yao Z, Harp K, Gwon DY, Chen Z, Siu KC. Effects of virtual reality in the early-stage stroke rehabilitation: A systematic review and meta-analysis of randomized controlled trials. Physiother Theory Pract. 2023 Dec 2;39(12):2569-2588. doi: 10.1080/09593985.2022.2094302. Epub 2022 Jul 7.

  PMID: 35801290 BACKGROUND

• da Silva Cameirao M, Bermudez I Badia S, Duarte E, Verschure PF. Virtual reality based rehabilitation speeds up functional recovery of the upper extremities after stroke: a randomized controlled pilot study in the acute phase of stroke using the rehabilitation gaming system. Restor Neurol Neurosci. 2011;29(5):287-98. doi: 10.3233/RNN-2011-0599.

  PMID: 21697589 BACKGROUND

• Lee SJ, Chun MH. Combination transcranial direct current stimulation and virtual reality therapy for upper extremity training in patients with subacute stroke. Arch Phys Med Rehabil. 2014 Mar;95(3):431-8. doi: 10.1016/j.apmr.2013.10.027. Epub 2013 Nov 14.

  PMID: 24239790 BACKGROUND

• Chen L, Lo WL, Mao YR, Ding MH, Lin Q, Li H, Zhao JL, Xu ZQ, Bian RH, Huang DF. Effect of Virtual Reality on Postural and Balance Control in Patients with Stroke: A Systematic Literature Review. Biomed Res Int. 2016;2016:7309272. doi: 10.1155/2016/7309272. Epub 2016 Dec 7.

  PMID: 28053988 BACKGROUND

• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

  PMID: 29156493 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shang-Lin Chiang, MD, PHD

  Tri-Service General Hospital, National Defense Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Participants were divided into two groups: the experimental group, which received early rehabilitation combined with VR training, and the comparison group, which received only early rehabilitation.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 3, 2023
• Study Start: April 12, 2017
• Primary Completion: August 12, 2018
• Study Completion: December 31, 2018
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)