UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026816 |
|---|---|
| Receipt number | R000030786 |
| Scientific Title | Study of motion analysis and training effect on the sitting lateral transfer in healthy person and patients with central nervous system disorders. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/04/04 10:29:37 |
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Basic information
Public title
Study of motion analysis and training effect on the sitting lateral transfer in healthy person and patients with central nervous system disorders.
Acronym
Study of motion analysis and training effect on the sitting lateral transfer.
Scientific Title
Study of motion analysis and training effect on the sitting lateral transfer in healthy person and patients with central nervous system disorders.
Scientific Title:Acronym
Study of motion analysis and training effect on the sitting lateral transfer.
Region
| Japan |
Condition
Condition
Healthy person and patients with central nervous system disorders
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the motion analysis on the sitting lateral transfer.
To verify the training method on the sitting lateral transfer based on analyzed motion patterns.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The kinematic data and the kinetic data (includes 3D motion analysis, electromyography, force reaction, seat pressure).
Key secondary outcomes
Observational motion pattern analysis, Functional Independence Measure, the data of body function (includes range of motion, manual muscle test, grip force) and vital sign (includes heart rate, blood pressure, SpO2).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Practice lateral transfer based on data of motion analysis.
Interventions/Control_2
Usual care only.
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. The subjects who have given written informed consent by themselves.
2. The subjects who can sit independently.
3. The subjects who can transfer between a bed and a wheelchair.
4. The patients with supra-tentorial lesion.
5. The patients with hemiplegia.
6. The patients without apparent paralysis in the unaffected limbs.
Key exclusion criteria
1. The subjects whose general condition was poor.
2. The subjects having difficulties in understanding the study design, providing consent to, or participating in the study due to cognitive impairment, aphasia or dementia.
3. The subjects presenting severe joint deformation including degenerative deformity.
4. The subjects who are decided by a doctor or investigator as being inappropriate for entry into the present study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University, School of Medicine
Division name
Department of Rehabilitation Medicine I
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Kondo |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-9720
Homepage URL
khikaru@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Aichi Science & Technology Foundation: Aichi Synchrotron Radiation Center, Knowledge Hub Aichi Priority Research Project
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research IRB, Center for research promotion and support, Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学（愛知県）
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030786
