UMIN-CTR Clinical Trial

Basic information
Public title	Observation of virtual reality-guided rehabilitation for spinocerebellar degeneration
Acronym	SCDVR study
Scientific Title	Observation of virtual reality-guided rehabilitation for spinocerebellar degeneration
Scientific Title:Acronym	SCDVR study
Region	Japan

Condition
Condition	spinocerebellar degeneration
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Observation of clinical items before and after rehabilitation using Virtual Reality for patients with spinocerebellar degeneration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical items after rehabilitation(SARA,BBS,FAC,FIM,TUG,10m walk test)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	A person who has been diagnosed with spinal cerebellar degeneration (hereditary spinocerebellar degeneration, cortical cerebellar atrophy, multiple system atrophy) or clinically suspected
Key exclusion criteria	A person who can not hold sittin
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Inagaki
Organization	Shimane University
Division name	Department of Neurology
Zip code	693-8501
Address	89-1 Shioji-cho, Izumo-shi, Shimane
TEL	0853-20-2198
Email	inasato@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Inagaki
Organization	Shimane University
Division name	Department of Neurology
Zip code	693-8501
Address	89-1 Shioji-cho, Izumo-shi, Shimane
TEL	0853-20-2198
Homepage URL
Email	inasato@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	Shimane University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	mediVR corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Shimane University
Address	89-1 Shioji-cho, Izumo-shi, Shimane
Tel	0853-20-2515
Email	Kenkyu@med.shimane-u.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	2019 Year 11 Month 20 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	Terminated
Date of protocol fixation	2019 Year 11 Month 20 Day
Date of IRB	2019 Year 11 Month 27 Day
Anticipated trial start date	2019 Year 11 Month 20 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation of clinical items before and after rehabilitation using Virtual Reality

Management information
Registered date	2019 Year 11 Month 20 Day
Last modified on	2021 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044030