UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025766 |
|---|---|
| Receipt number | R000029637 |
| Scientific Title | Investigation on safety and applicability of imitative learning as home based exercise for chronic hemiplegia |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2019/01/24 18:23:41 |
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Basic information
Public title
Investigation on safety and applicability of imitative learning as home based exercise for chronic hemiplegia
Acronym
Investigation on safety and applicability of imitative learning as home based exercise for chronic hemiplegia
Scientific Title
Investigation on safety and applicability of imitative learning as home based exercise for chronic hemiplegia
Scientific Title:Acronym
Investigation on safety and applicability of imitative learning as home based exercise for chronic hemiplegia
Region
| Japan |
Condition
Condition
Hemiplegia after stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many stroke patients have difficulty to perform an activity of daily living, because the paretic limb function does not recover completely.
Imitation learning is one of the most efficient motor learning methods, and thus can be an effective way of promoting motor recover in rehabilitation in hemiplegia after stroke. Furthermore, imitation training of imitation learning can be performed by one person, and does not require expensive equipment. Therefore, imitation training can be useful for home based exercise of stroke patients with hemiparesis after discharged home.
Transmissive head mounted displays (T-HMD) marketed in recent years have a potential to gain better learning effect in imitation training, because T-HMD make it possible to compare the movement of a model and the self-movement directly. However, it is unclear that T-HMD is enough safety for home-based rehabilitation of stroke patients with hemiplegia.
Therefore, in this research, we investigate whether participants could perform imitation learning using T-HMD at home without adverse event. In addition, we examine the effect of imitation learning using T-HMD as home based exercise on motor impairment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants perform imitative training using the T-HMD every day during the 4 weeks. In imitation training, the patients imitate finger flexion / extension movement presented on T-HMD with paralyzed hand. The finger flexion / extension movement as a cycle is repeated 10 times at 0.25Hz in1 session, and participants will perform 10 sessions each day.
If virtual reality sickness such as dizziness or nausea occurs during intervention, the patients are required to stop the intervention immediately. Research will also be stopped if patients have a trouble during training. The intervention will be terminated when 280 sessions are done in total. In the case of forgetting to perform or bad health condition, the intervention period shall be extended until 280 sessions are achieved.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with first time stroke
(2) More than one year passed since stroke onset
(3) Over 20 years old
(4) Agree to participate our research
(5) Maximum systolic pressure at rest is less than 150 mmHg
(6) Patients who can go from home to university hospital by themselves
Key exclusion criteria
(1) Patients with a neurological history other than stroke
(2) Patients with musculoskeletal disorders in upper limb
(3) Patients with aphasia
(4) Patients who has pain during exercise
(5) Patients with cerebral cortex injury
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Izumi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Sato |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
Homepage URL
drugsatou@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SEIKO EPSON CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 20 | 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
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | 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=R000029637
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
