UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046123 |
|---|---|
| Receipt number | R000052643 |
| Scientific Title | Examining the effect of an intervention using a Flex controller on the accessibility of games for subjects with upper limb dysfunction |
| Date of disclosure of the study information | 2021/11/22 |
| Last modified on | 2022/12/19 15:41:41 |
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Basic information
Public title
Examining the effect of an intervention using a Flex controller on the accessibility of games for subjects with upper limb dysfunction
Acronym
Testing the effectiveness of interventions using the Flex controller
Scientific Title
Examining the effect of an intervention using a Flex controller on the accessibility of games for subjects with upper limb dysfunction
Scientific Title:Acronym
Testing the effectiveness of interventions using the Flex controller
Region
| Japan |
Condition
Condition
patients with upper extremity dysfunction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of an intervention using the Flex controller on accessibility, social isolation and caregiver burden
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Canadian Occupational Performance Measure, Game playing time, Frequency of game play, Japanese version of the UCLA Loneliness Scale, Feeling of burden of childcare, Steps for Coding and Theorization (SCAT)
Key secondary outcomes
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 |
Interventions/Control_1
Using the Flex controller
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
| 6 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-People with upper extremity dysfunction due to cerebral palsy, muscular dystrophy, spinal muscular atrophy, stroke, etc.
-No significant cognitive impairment and able to understand the purpose of the game.
-The subject himself/herself expresses a desire to participate in the game.
-Experience of difficulty in participating in the game or experience of giving up participation
Key exclusion criteria
-Patients who have been judged by the applicants to be ineligible for the Flex controller
-Have used or are currently using a Flex controller
-Has a diagnosis of severe to moderate intellectual disability.
-Have a history of epilepsy.
-A doctor has judged that the patient is unable to participate in the study.
-Any other person who is judged by the applicants to be unsuitable as a subject for this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Naga |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Odawara
Zip code
250-8588
Address
1-2-25
TEL
0465-21-6722
s-naga@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Naga |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Odawara
Zip code
250-8588
Address
1-2-25, Shiroyama, Odawara-shi, Kanagawa
TEL
0465-21-6722
Homepage URL
s-naga@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Kanagawa association of occupational therapists
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-2-25, Shiroyama, Odawara-shi, Kanagawa
Tel
0465-21-6722
s-naga@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | 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
| 2021 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052643
