UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053432 |
|---|---|
| Receipt number | R000060704 |
| Scientific Title | Investigation of effectiveness to improve upper extremity function of the affected side of observing video images on a tablet in acute stroke patients - Randomized Controlled Trial- |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2025/01/24 01:08:00 |
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Basic information
Public title
Investigation of effectiveness of observing video images on a tablet for paralyzed arm in acute stroke patients
Acronym
ASTET(Acute Stroke Tablet Effectiveness Test)
Scientific Title
Investigation of effectiveness to improve upper extremity function of the affected side of observing video images on a tablet in acute stroke patients - Randomized Controlled Trial-
Scientific Title:Acronym
ASTT(Acute Stroke Tablet Trial)
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect on the function of the affected upper extremity by inducing motor illusions in acute stroke patients by taking motor video images of the unaffected upper extremity using a tablet in advance and placing the tablet on the affected upper extremity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment upper extremity.
Time of evaluation: before the intervention, every 5 interventions, before discharge from the acute care ward, and after 1, 3, and 6 months of the intervention.
Key secondary outcomes
Japanese Version of Motor Activity Log
Time of evaluation: before the intervention, every 5 interventions, before discharge from the acute care ward, and after 1, 3, and 6 months of the intervention.
Visual Analog Scale
Time of evaluation: before the intervention, every 5 interventions, before discharge from the acute care ward.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the intervention group, the observation of video images on a tablet is performed as an additional therapy to conventional rehabilitation ( physical therapy, occupational therapy, and speech therapy). First, the affected forearm is inserted into a self-made tablet box placed on a desk. Next, the size and position of the video image are adjusted to induce a motion illusion, and the degree of motion illusion is assessed using a Visual Analog Scale. The tablet is set to mute so that auditory stimuli are not present during the observing video images. The instruction is "Please observe the video images without moving your hands" and only visual stimuli are used. During video image observation, the upper extremity of the unaffected side should be kept out of sight, such as under a desk. The motion content of the observing video images should include forearm supination/pronation, wrist flexion/extension, finger open/close, opposite thumb and index finger, thumb adduction/abduction, and hook grip. Video images should be observed for 30 minutes per session, 5 times per week, until discharge. Breaks will be provided at appropriate intervals. The observation of video images will last for 38 seconds, with the first 3 seconds displaying the exercise on a black screen in text, followed by 5 seconds to adjust the size and position of the vdeo with a still image of the hand, and the remaining 30 seconds for actual video observation. There will be a total of 6 exercises, lasting 3.8 minutes. For individuals who experiencing fatigue or poor attentional focus, it is recommended to maintain the intervention time and instead adjust by incorporating more breaks or shortening the observation time per movement.
Interventions/Control_2
The control group will receive only usual rehabilitation (physical therapy, occupational therapy, speech therapy).
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) written informed consent to participate in this study,
(2) age 20-90 years
(3) within 2 weeks of stroke onset
(4) Brunnstrom Recovery Stage 3-5 in the upper extremity
(5) Mini-Mental State Examination score of 24 or higher
(6) ability to maintain a sitting position
(7) first stroke
(8) recurrent stroke but no residual upper extremity functional impairment at the time of the previous stroke.
Key exclusion criteria
(1) presence of muscle hypertonia, pain, limited joint range of motion, or orthopedic disease that significantly interferes with upper extremity function
(2) presence of cerebellar lesions or malignancy
(3) obvious visual impairment, visual field constriction, or eye movement disorder
(4) obvious cognitive decline or higher brain dysfunction
(5) severe heart, liver, or kidney disease.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kubo |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Odawara
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara-shi, Kanagawa
TEL
0465-21-6500
akubo@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kanta |
| Middle name | |
| Last name | Kosuge |
Organization
Graduate School of International University of Health and Welfare
Division name
Department of Health and Medical Sciences
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara-shi, Kanagawa
TEL
0465-21-6500
Homepage URL
22s3049@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishou Hospital
Tsurumakionsen Hospital
Hakonerehabilitation Hospital
Manaka Hospital
Kobayashi Hospital
Chigasaki Rehabilitation College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of International University of Health and Welfare
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@iuhw.ac.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
| 2024 | Year | 01 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 10 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060704
