Early Rehab With VR for First-time Acute Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05929742
• Other study ID #: 001-VR
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2024
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2018
• Est. primary completion date: August 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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