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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025766
Receipt No. 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

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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
Email 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
Email drugsatou@gmail.com

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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