UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062608 |
|---|---|
| Receipt number | R000071658 |
| Scientific Title | Comparison of the Effects and Response Characteristics of Visual-Motor Illusion Interventions Using Mirror Therapy and KINVIS in Patients With Post-Stroke Upper Limb Motor Paresis |
| Date of disclosure of the study information | 2026/08/18 |
| Last modified on | 2026/08/18 21:26:45 |
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Basic information
Public title
Comparison of Two Visual-Motor Illusion Therapies for Upper Limb Paresis After Stroke
Acronym
VMI Comparison Study
Scientific Title
Comparison of the Effects and Response Characteristics of Visual-Motor Illusion Interventions Using Mirror Therapy and KINVIS in Patients With Post-Stroke Upper Limb Motor Paresis
Scientific Title:Acronym
MVK Study
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare mirror therapy and KINVIS within the same patients with post-stroke upper limb paresis and to investigate differences in the effects and response characteristics of visual-motor illusion interventions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Upper limb motor function is assessed using the upper extremity section of the Fugl-Meyer Assessment (FMA-UE). Assessments are performed during the baseline period and after each intervention (after mirror therapy and after KINVIS) to evaluate changes in upper limb motor function associated with each intervention.
Key secondary outcomes
Secondary outcomes include sensory function assessed using the sensory items of the Stroke Impairment Assessment Set (SIAS); maximum muscle activity (MVC) and co-contraction index (CCI) of the flexor digitorum superficialis and extensor carpi radialis longus measured using surface electromyography (EMG); sense of agency and body ownership assessed using visual analogue scales (VAS); the Modified Ashworth Scale (MAS); and the KVIQ-10. These outcomes are assessed during the baseline period and after each intervention (after mirror therapy and after KINVIS) to evaluate intervention-related changes and differences in response characteristics.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Mirror therapy is administered using the mirror image of finger flexion and extension movements of the non-paretic hand to induce a visual-motor illusion in which the paretic upper limb appears to be moving. The intervention is performed for 20 minutes once daily, 5 times per week, with 5 sessions constituting one intervention set. A 1-week washout period is provided between the mirror therapy and KINVIS intervention periods.
Interventions/Control_2
KINVIS (Kinesthetic Illusion Induced by Visual Stimulation) is administered using a video of finger flexion and extension movements presented as if the paretic upper limb were actually moving, thereby inducing a kinesthetic illusion without actual movement of the paretic limb. The intervention is performed for 20 minutes once daily, 5 times per week, with 5 sessions constituting one intervention set. A 1-week washout period is provided between the KINVIS and mirror therapy intervention periods.
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
| 20 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with stroke admitted to a convalescent rehabilitation ward
Patients with a first-ever stroke
Patients with upper limb motor paresis
Right-handed patients
Patients with normal or adequately corrected visual acuity
Key exclusion criteria
Patients with a history of neurological or psychiatric disorders
Patients with orthopedic disorders affecting the upper limb
Patients with aphasia
Patients who are unable to understand the purpose of this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | kento |
| Middle name | |
| Last name | sasayama |
Organization
iryouhoujin eisinkai kisiwada rehabilitation hospital
Division name
rehabilitation
Zip code
5960827
Address
osakahu kisiwadacity kanmatutyo 2-8-10
TEL
072-426-7777
sasayama.kento@gmail.com
Public contact
Name of contact person
| 1st name | kento |
| Middle name | |
| Last name | sasayama |
Organization
iryouhoujinn eisinkai kisiwada rehabilitation hospital
Division name
rehabilitation
Zip code
5960825
Address
osakahu kisiwadacity habutyo 13-11-9 202
TEL
08020758497
Homepage URL
sasayama.kento@gmail.com
Sponsor or person
Institute
iryouhoujinn eisinkai kisiwada rehabilitation hospital
Institute
Department
Personal name
sasayama kento
Funding Source
Organization
iryouhoujinn eisinkai kisiwada rehabilitation hospital
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
Kishiwada Rehabilitation Hospital Ethics Review Committee
Address
osakahu kisiwadacity kanmatutyo 2-8-10
Tel
0724267777
sasayama.kento@gmail.com
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 | 08 | Month | 18 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071658
