UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025237 |
|---|---|
| Receipt number | R000028912 |
| Scientific Title | Motion and electromyographical analysis of stroke rehabilitation |
| Date of disclosure of the study information | 2016/12/14 |
| Last modified on | 2024/01/23 05:59:30 |
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Basic information
Public title
Motion and electromyographical analysis of stroke rehabilitation
Acronym
Motion and EMG analysis of stroke rehabilitation
Scientific Title
Motion and electromyographical analysis of stroke rehabilitation
Scientific Title:Acronym
Motion and EMG analysis of stroke rehabilitation
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective evaluation of the effect of stroke rehabilitation
Basic objectives2
Others
Basic objectives -Others
evaluation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Kinematic parameter and EMG pattern associated with motion
Key secondary outcomes
Fugl-Meyer Assessment
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
| Maneuver |
Interventions/Control_1
Evaluation of performances (standing up, walking or movement of the paralytic upper extremity) immediately before and after ten-minute rehabilitation by 3D motion analysis and electromyography.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients having first-ever stroke.
Patients whose general medical condition is stable (by reference to the criteria by Anderson-Doi)
Patients who receive physical or occupational therapy including the exercise equivalent to or more advanced than the movement planned in the study.
Patients who can sit by themselves.
Key exclusion criteria
Patients whose general condition was poor to perform the task.
Patients having difficulties in understanding the study design, providing consent to, or participating in the study due to hearing or visual impairment, cognitive impairment, aphasia or dementia.
Patients having past history of severe neurological or psychiatric diseases such as brain tumor, epilepsy, Parkinson's disease.
Patients having contraindication for MRI.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyai |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
536-0025
Address
2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL
0669698170
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Miyata |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
536-0025
Address
2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL
0669698170
Homepage URL
miyata@omichikai.or.jp
Sponsor or person
Institute
Neurorehabilitation Research Institute, Morinomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Neurorehabilitation Research Institute, Morinomiya Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN Brain Science Institute
National Institute of Neuroscience, National Center for Neurology and Psychiatry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omichikai Meidical Corporation
Address
1-5-1, Higashinakahama, Joto-ku, Osaka-shi, Osaka, Japan
Tel
06-6962-9621
nrri-jimu@omichikai.or.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
| 2016 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Published
Result
URL related to results and publications
https://ieeexplore.ieee.org/document/8304747
Number of participants that the trial has enrolled
12
Results
Stroke patients had inadequate muscle synergy structure, but the intervention by physical therapists (PTs) could improve the standing-up motion. Some patients had delayed activation of the synergy and could only stood up after they moved their center of mass toward their feet. However, the intervention by PTs could induce earlier activation of the synergy. Moreover, the intervention could properly shorten the activation duration of synergy for those who had unusually inappropriate longer synergy activation.
Results date posted
| 2024 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twelve hemiplegic patients with stroke (ten male and two female, mean age of 56.0 years old) participated in the experiment. Nine patients had paralysis on the left side, and three patients had it on the right side.In addition,eight healthy elderly people (8 males, mean age of 64.4 years old) participated in this experiment.
Participant flow
The participants were asked to stand without using their arms. Ten trials were conducted, in which the participants stood up on their own, and ten trials were conducted with intervention by PTs.
Adverse events
No adverse events were observed.
Outcome measures
Kinematic data and muscle synergy data were measured during the standing up motion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | 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
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028912
