Stroke, AcuteNCT05929742
Early Rehab With VR for First-time Acute Stroke
A study testing virtual reality training and early rehabilitation in people with Stroke, Acute and Acute Ischemic Stroke, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Acute, Acute Ischemic Stroke
- What is being tested?
- virtual reality training and early rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center
Taipei, 114
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute, Acute Ischemic Stroke
- Being tested
- virtual reality training, early rehabilitation
- Keywords
- Early rehabilitation, Virtual reality
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality trainingBehavioural
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 rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | received early rehabilitation combined with VR training Receives: Behavioral: virtual reality training; Behavioral: early rehabilitation |
| comparison group | Active comparator | received only early rehabilitation Receives: Behavioral: early rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through the admission period, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 Apr 2017
- Primary completion12 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Chung Chao, National Defense Medical Center, Taiwan
- Investigators
- Shang-Lin Chiang, MD, PHD, Study director, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929742
- Sponsor's protocol ID
- 001-VR
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34747351Hao 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.
PubMed 35801290da 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.
PubMed 21697589Lee 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.
PubMed 24239790Chen 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.
PubMed 28053988Laver 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.
PubMed 29156493
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Early Rehabilitation Combined With Virtual Reality Training in Patients With First-time Acute Stroke
- ClinicalTrials.gov ID
- NCT05929742
- Acronym / sponsor ID
- 001-VR
- Conditions
- Stroke, Acute, Acute Ischemic Stroke
- Keywords
- Early rehabilitation, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 12 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: virtual reality training, Behavioral: early rehabilitationreceived early rehabilitation combined with VR training |
| comparison group | Active comparator | Behavioral: early rehabilitationreceived only early rehabilitation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality trainingThe experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward. | Behavioural | experimental group |
| early rehabilitationFive 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. | Behavioural | comparison group, experimental group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 34747351Khan 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.
- Background: PubMed 35801290Hao 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.
- Background: PubMed 21697589da 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.
- Background: PubMed 24239790Lee 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.
- Background: PubMed 28053988Chen 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.
- Background: PubMed 29156493Laver 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shang-Lin Chiang, MD, PHD study director
Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality training and early rehabilitation in people with Stroke, Acute and Acute Ischemic Stroke, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: through the admission period, an average of 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929742, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.