UMIN-CTR Clinical Trial

Basic information
Public title	Investigating the feasibility of a computer graphics-based recreational exercise system on facilitating active movement in disabled people
Acronym	Feasibility of a computer graphics-based recreational exercise system
Scientific Title	Investigating the feasibility of a computer graphics-based recreational exercise system on facilitating active movement in disabled people
Scientific Title:Acronym	Feasibility of a computer graphics-based recreational exercise system
Region	Japan

Condition
Condition	Healthy adults and patients with motor impairment in the upper extremity
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the feasibility and efficacy of a computer graphics-based recreational exercise system on disabled people
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective and objective evaluation using a questionnaire.
Key secondary outcomes	Facial expressions evaluated by facial image analysis, kinematic analysis of upper-limb movements, and clinical indices for motor functions

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	Device,equipment Behavior,custom
Interventions/Control_1	Motor activity using a CG-based exercise system, subjective evaluation with a questionnaire, recording motor activity or face, kinematic analysis, and clinical evaluation of motor functions
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults -A person with no past history of brain diseases or neurologic/muscular diseases -Consent to participate in the study Patients -A person referred to a rehabilitation department for motor impairments in the upper extremity -Consent to participate in the study
Key exclusion criteria	Healthy adults -Past history of brain diseases or neurologic/muscular diseases Patients -Unstable medical conditions
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Otaka
Organization	Fujita Health University
Division name	Department of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Uehara
Organization	Fujita Health University
Division name	Faculty of Rehabilitation, School of Health Sciences
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562-93-9000
Homepage URL
Email	suehara@fujita-hu.ac.jp

Sponsor
Institute	Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	SPEED Inc. SMK Corporation Institute of Innovative Research, Tokyo Institute of Technology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Research Ethics Review Committee, Research Promotion and Support Headquarters, Fujita Health University
Address	1-98, Dengakugakubo, Kutsukake-cho, 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	藤田医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information	2020 Year 02 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	2020 Year 01 Month 28 Day
Date of IRB	2020 Year 01 Month 09 Day
Anticipated trial start date	2020 Year 01 Month 28 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 02 Month 01 Day
Last modified on	2020 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044758