UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042328 |
|---|---|
| Receipt number | R000048317 |
| Scientific Title | Adjustment of motor control induced by EMG-based feedback training |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2020/11/02 18:20:09 |
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Basic information
Public title
Adjustment of motor control induced by EMG-based feedback training
Acronym
The effect of physical training used feedback system based on EMG information
Scientific Title
Adjustment of motor control induced by EMG-based feedback training
Scientific Title:Acronym
Adjustment of motor control induced by EMG-based feedback training
Region
| Japan |
Condition
Condition
Healthy subjects and Stroke patients
Classification by specialty
| Neurology | Geriatrics | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop the novel rehabilitative training system used network analysis of the muscles-activity information measured by EMG.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of Pressure on the force plate
Force adjustment (Target match) test
EMG-EMG/EEG-EMG coherence
Key secondary outcomes
Questionnaire for Fatigue, Concentration, Sleepiness
Vital sign
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Real-time feedback training through network analysis of EMG information
Interventions/Control_2
Sham control group used EMG information with noise
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
Experiment1. Healthy young adults
Experiment2. Healthy young adults and Healthy elderly
Experiment3. Stroke patients met the following inclusion criteria
1) Patients admitted to a convalescent rehabilitation ward
2) Patients with stable condition
3) Patients singed an informed consent document.
Key exclusion criteria
1) a clip or other metal in the skull
2) a cardiac pacemaker
3) taking medicines such as antidepressants or antipsychotics
4) Patients with epilepsy or a family history of epilepsy
5) Other subjects whose health may be affected by this research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ippei |
| Middle name | |
| Last name | Nojima |
Organization
Shinshu University, Department of Health Sciences
Division name
Applied Physical Therapy
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-37-2408
nojima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Nojima |
Organization
Shinshu University, Department of Health Sciences
Division name
Applied Physical Therapy
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-37-2408
Homepage URL
nojima@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu 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
National Hospital Organization Higashinagoya National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University, Ethics Committee
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2021 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | 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 | 11 | Month | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048317
| Research Plan | |
|---|---|
| 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 |
