UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039359 |
|---|---|
| Receipt number | R000044758 |
| Scientific Title | Investigating the feasibility of a computer graphics-based recreational exercise system on facilitating active movement in disabled people |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/02/01 20:31:51 |
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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
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
suehara@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044758
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
