UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062166 |
|---|---|
| Receipt number | R000071142 |
| Scientific Title | The Effects of Seated Balance Training Using mediVR Kagura in Patients with Acute Stroke: An Exploratory Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/09 |
| Last modified on | 2026/07/08 00:47:52 |
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Basic information
Public title
A Study of Seated Balance Training Using a Virtual Reality Device in Patients with Acute Stroke
Acronym
VR-SEAT trial
Scientific Title
The Effects of Seated Balance Training Using mediVR Kagura in Patients with Acute Stroke: An Exploratory Pilot Randomized Controlled Trial
Scientific Title:Acronym
VR-SEAT trial
Region
| Japan |
Condition
Condition
cerebral infarction, cerebral hemorrhage
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of adding seated VR training to conventional physical therapy in patients with acute stroke, and to preliminarily estimate effect sizes to inform a subsequent confirmatory RCT.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility: enrollment rate (at the end of the 14-month recruitment period; threshold >=50%), intervention completion rate (completion of >=8 of 10 sessions during the 14-day intervention period; threshold >=70%), data acquisition rate for the Trunk Impairment Scale (TIS) total score at both baseline and 14 days (+/-2 days) after baseline (threshold >=80%), and incidence of study-related serious adverse events throughout the study period (threshold <5%)
Key secondary outcomes
1. Change in Trunk Impairment Scale (TIS) total score from baseline to 14 days (+/-2 days) after baseline [exploratory primary efficacy indicator]
2. Change in Fugl-Meyer Assessment (FMA) score from baseline to 14 days (+/-2 days) after baseline
3. Change in Functional Ambulation Categories (FAC) from baseline to 14 days (+/-2 days) after baseline
4. Change in Timed Up & Go Test (TUG) from baseline to 14 days (+/-2 days) after baseline (only in participants able to stand and walk)
5. Change in Functional Independence Measure (FIM) score from baseline to 14 days (+/-2 days) after baseline
6. Discharge destination (at discharge)
7. Internal data from mediVR Kagura (task success rate, total number of reaches, and changes in task parameters during the intervention period)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: In addition to conventional physical therapy (40 min/day), patients receive seated VR training using mediVR Kagura (20 min/day), for a total of 60 min/day. The VR task is a seated reaching task (horizontal game) in which patients reach for targets presented in the VR space using a hand-held controller. The size, distance, and range of the targets are adjusted according to each patient's physical function. If patients have difficulty holding the controller with the paretic upper limb, the controller is fixed to the shoulder with a band. The VR training is performed 10 sessions in total over 14 days, starting from day 5 or later after stroke onset. Conventional physical therapy includes range-of-motion exercises, muscle strengthening, gait training, and ADL training. Occupational therapy and speech therapy are provided to both groups with equivalent frequency and duration as needed.
Interventions/Control_2
Control group: Patients receive conventional physical therapy for 60 min/day for 14 days, including range-of-motion exercises, muscle strengthening, sitting and standing balance training, sit-to-stand training, gait training, and ADL training, with qualitative content equivalent to the conventional physical therapy provided to the intervention group. Occupational therapy and speech therapy are provided to both groups with equivalent frequency and duration as needed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with first-ever supratentorial cerebral infarction or intracerebral hemorrhage (excluding subarachnoid hemorrhage)
2. Within 5 to 10 days after stroke onset
3. Aged 18 years or older and younger than 85 years
4. Functional Ambulation Categories (FAC) 0-2 (unable to walk to walking with assistance)
5. Able to maintain a sitting position on the edge of the bed for at least 1 minute
6. Mini Mental State Examination (MMSE) score of 20 or higher
7. Japan Coma Scale (JCS) of single-digit or better, with the ability to understand the assessments and VR tasks
8. Patients who received an explanation of the study and provided written informed consent
Key exclusion criteria
1. Patients with severe visual or hearing impairment that makes it difficult to perform the VR tasks
2. Patients with a history of adverse events such as VR sickness (cybersickness)
3. Patients for whom exercise therapy is contraindicated due to active infection, fracture, severe pain, hemodynamic instability, or other conditions
4. Patients judged inappropriate for participation by the attending physician or study investigators from the perspective of safety or study validity
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | yutaka |
| Middle name | |
| Last name | kamonzeki |
Organization
Southern Tohoku General Hospital, Southern Tohoku Research Institute for Neuroscience
Division name
Department of Rehabilitation
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima, Japan
TEL
024-934-5570
info@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | yutaka |
| Middle name | |
| Last name | kamonzeki |
Organization
Southern Tohoku General Hospital, Southern Tohoku Research Institute for Neuroscience
Division name
Department of Rehabilitation
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima, Japan
TEL
024-934-5570
Homepage URL
info@mt.strins.or.jp
Sponsor or person
Institute
Southern Tohoku General Hospital, Southern Tohoku Research Institute for Neuroscience
Institute
Department
Personal name
yutaka kamonzeki
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Southern Tohoku General Hospital, Southern Tohoku Research Institute for Neuroscience
Address
7-115 Yatsuyamada, Koriyama, Fukushima, Japan
Tel
024-934-5570
info@mt.strins.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 05 | Month | 31 | Day |
Other
Other related information
1. To minimize assessment bias, the Trunk Impairment Scale (TIS), the exploratory primary efficacy indicator, is assessed by assessors not involved in the intervention whenever possible.
2. Progression criteria to a subsequent confirmatory randomized controlled trial: if all four feasibility criteria (enrollment rate >=50%, intervention completion rate >=70%, data acquisition rate >=80%, and incidence of study-related serious adverse events <5%) are met, progression is recommended; if only one criterion is unmet, conditional progression with protocol modification is considered; if two or more criteria are unmet, reconsideration of the intervention or study design is required.
3. As an exploratory pilot trial, this study does not perform hypothesis testing to determine efficacy. The aim is to estimate effect sizes (Cohen's d) with 95% confidence intervals, and p-values are reported for reference only.
4. This trial will be reported in accordance with the CONSORT 2010 statement: extension to randomised pilot and feasibility trials (Eldridge SM, et al. BMJ. 2016;355:i5239).
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071142
