Back to resultsEarly Rehab With VR for First-time Acute Stroke
Primary Purpose
Stroke, Acute, Acute Ischemic Stroke
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
virtual reality training
early rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring Early rehabilitation, Virtual reality
Eligibility Criteria
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.
Sites / Locations
- Tri-Service General Hospital, National Defense Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
comparison group
Arm Description
received early rehabilitation combined with VR training
received only early rehabilitation
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05929742
First Posted
June 13, 2023
Last Updated
June 29, 2023
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05929742
Brief Title
Early Rehab With VR for First-time Acute Stroke
Official Title
The Efficacy of Early Rehabilitation Combined With Virtual Reality Training in Patients With First-time Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
August 12, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Acute Ischemic Stroke
Keywords
Early rehabilitation, Virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
received early rehabilitation combined with VR training
Arm Title
comparison group
Arm Type
Active Comparator
Arm Description
received only early rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
virtual reality training
Intervention Description
The experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward.
Intervention Type
Behavioral
Intervention Name(s)
early rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
muscle strength
Description
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.
Time Frame
through the admission period, an average of 1 month
Title
postural control
Description
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.
Time Frame
through the admission period, an average of 1 month
Title
activities of daily living
Description
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.
Time Frame
through the admission period, an average of 1 month
Title
mood state
Description
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.
Time Frame
through the admission period, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shang-Lin Chiang, MD, PHD
Organizational Affiliation
Tri-Service General Hospital, National Defense Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Tri-Service General Hospital, National Defense Medical Center
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
34747351
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.
Results Reference
background
PubMed Identifier
35801290
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. 2022 Jul 7:1-20. doi: 10.1080/09593985.2022.2094302. Online ahead of print.
Results Reference
background
PubMed Identifier
21697589
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.
Results Reference
background
PubMed Identifier
24239790
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.
Results Reference
background
PubMed Identifier
28053988
Citation
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.
Results Reference
background
PubMed Identifier
29156493
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.
Results Reference
background
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Early Rehab With VR for First-time Acute Stroke
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