UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054226 |
|---|---|
| Receipt number | R000061866 |
| Scientific Title | The Effectiveness of Fast-Forward Action Observation and Motor Imagery Training and the Verification of Target Training Repetitions for Improving the Paretic Upper Limb in Patients with Severe Post-Stroke Hemiparesis |
| Date of disclosure of the study information | 2025/01/04 |
| Last modified on | 2025/12/04 19:19:17 |
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Basic information
Public title
The Effectiveness of Fast-Forward Action Observation and Motor Imagery Training and the Verification of Target Training Repetitions for Improving the Paretic Upper Limb in Patients with Severe Post-Stroke Hemiparesis
Acronym
The Effectiveness of Fast-Forward Action Observation and Motor Imagery Training and the Verification of Target Training Repetitions for Improving the Paretic Upper Limb in Patients with Severe Post-Stroke Hemiparesis
Scientific Title
The Effectiveness of Fast-Forward Action Observation and Motor Imagery Training and the Verification of Target Training Repetitions for Improving the Paretic Upper Limb in Patients with Severe Post-Stroke Hemiparesis
Scientific Title:Acronym
The Effectiveness of Fast-Forward Action Observation and Motor Imagery Training and the Verification of Target Training Repetitions for Improving the Paretic Upper Limb in Patients with Severe Post-Stroke Hemiparesis
Region
| Japan |
Condition
Condition
Stroke hemiplegia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficiency of Action Observation Motor Imagery (AOMI) training
Basic objectives2
Others
Basic objectives -Others
Providing training data to enhance the reproducibility of Event-Related Desynchronization (ERD) in Brain-Computer Interface (BCI) for robot therapy, aiming to improve training efficiency for patients to use their paralyzed hand in some activities of daily living (ADLs).
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Fugl-Meyer Assessment UpperExtremity
Key secondary outcomes
1) ERD Power
2) Kinesthetic and Visual Imagery Questionnaire: KVIQ-20 (sensory scales)
3) AOMI practice time until reaching 5040 trials
4) Optimal speed from 1x to 4.0x speed on the Visual Analog Scale: VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A video of the upper limb reaching forward is shown to patients with severe paralysis of stroke (FMA-UE score less than 20, MMSE score less than 24, and KVIQ score less than 75) in addition to the normal rehabilitation time, and give them an image of exercise.
In the video, one set of 60 reach movements is performed, and seven sets of these movements are performed in one training session, aiming for a total of 420 trials.
This training is performed three times a week for four weeks, and the training is completed after a total of 5,040 attempts.
Practice with the video playback speed set to 1.0x.
Interventions/Control_2
Show the video of reaching forward with the upper limb to stroke patients with severe paralysis (FMA-UE score less than 20, MMSE score less than 24, and KVIQ score less than 75) during regular rehabilitation sessions. In addition to the usual rehabilitation time, engage them in mental imagery of the movement.
The video depicts one set of 60 repetitions of reaching movements. Aim to complete 7 sets in one training session, totaling 420 repetitions. Repeat this training three times a week for four weeks, reaching a total of 5040 repetitions.
Practice at the playback speed that the patient subjectively evaluates as the most conducive for mental imagery, choosing from speeds of 1.5x, 2.0x, 3.0x, and 4.0x.
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
1) Those in the recovery phase exhibiting upper limb hemiparesis due to stroke.
2) Those with an MMSE score of 24 or higher, an FMA-UE score of less than 20, and a KVIQ-20 score of less than 74.
Key exclusion criteria
1) Those unable to perform motor imagery or tasks.
2) Individuals with a history of or current mental illness.
3) Those with central nervous system disorders other than stroke or orthopedic disorders significantly limiting recovery from paralysis.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamamoto |
Organization
Toda Chuo Rehabilitation Hospital
Division name
Rehabilitation Department
Zip code
335-0026
Address
4-1-29 Shinso Minami, Toda City, Saitama Prefecture
TEL
048
t_yamamoto3@tmg.or.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamamoto |
Organization
Saitama Prefectural University
Division name
Graduate School of Health, Medicine, and Welfare
Zip code
343-8540
Address
820 Sannomiya, Koshigaya City, Saitama Prefecture
TEL
0489710500
Homepage URL
2591009r@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University
Address
820 Sanomiya, Koshigaya City, Saitama Prefecture
Tel
0489710500
2591009r@spu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R5-5
Org. issuing International ID_1
Toda Chuo Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
戸田中央リハビリテーション病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061866
