UMIN-CTR Clinical Trial

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
Email	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
Email	khikaru@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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030786