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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026816
Receipt No. 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 2019/04/02

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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 Eiichi
Middle name
Last name Saitoh
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
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Tatemoto
Organization Fujita Health University Hospital
Division name Department of Rehabilitation
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-9720
Homepage URL
Email tatemoto@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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 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
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
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030786

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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