UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039244 |
|---|---|
| Receipt number | R000042894 |
| Scientific Title | A research on combined effects of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation for hemiparetic patients with stroke. |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/01/24 09:39:52 |
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Basic information
Public title
A research on combined effects of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation for hemiparetic patients with stroke.
Acronym
A research on the effect of kinesthetic illusion for patients with stroke.
Scientific Title
A research on combined effects of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation for hemiparetic patients with stroke.
Scientific Title:Acronym
A research on the effect of kinesthetic illusion for patients with stroke.
Region
| Japan |
Condition
Condition
Hemiparetic patients with stroke.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of combination therapy of kinesthetic illusion and neuromuscular electrical stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor functions will be assessed before and after intervention.
Motor function assessment: Fugl-Meyer Assessment upper limb exercise items and Action Research Assessment Test.
Key secondary outcomes
Motor functions will be assessed before and after intervention.
Motor function assessment: Stroke Impairment Assessment set upper limb exercise items and Box and Block Test.
Frequency of use in daily life: Motor Activity Log.
Muscle spasticity of upper limb: Modified Ashworth Scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
A combination of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation is performed for 10 minutes x 2 sets for 10 days on weekdays.
The visual stimulation is a video of the finger flexion and extension movement.
Neuromuscular electrical stimulation is performed at approximately 1.1 to 1.2 times the motor threshold of the extensor digitorum communis.
Interventions/Control_2
Therapeutic exercise for 20 minutes on upper limb for 10 days on weekdays.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients within 6 months after stroke onset.
First stroke patient.
20 years or older.
Patients who have obtained written consent for participation in this study.
Key exclusion criteria
Those who have difficulty in understanding the purpose and method of the study (regardless of cognitive or impaired high degree brain function).
Patients with aphasia.
SIAS distal item is 0.
Patients who can not take a time for physical and occupational therapy for more than 2 hours per day during the study period.
Those who are contraindicated for exercise therapy.
Those who are contraindicated for Magnetoencephalography and Magnetic Resonance Imaging.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Fuminari |
| Middle name | |
| Last name | Kaneko |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-5363-3833
f-kaneko@keio.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Okawada |
Organization
Keio University School od Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-5363-3833
Homepage URL
m-okawada@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3505
med-rinri-jimu@adst.keio.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
社会医療法人十勝リハビリテーションセンター（北海道）、社会医療法人恩賜財団済生会東神奈川リハビリテーション病院（神奈川）、医療法人社団保健会東京湾岸リハビリテーション病院（千葉）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2020 | Year | 01 | Month | 24 | Day |
Last modified on
| 2020 | 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=R000042894
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