UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on effects of home exercise on patients with spinocerebellar degeneration
Acronym	Effects of home exercise on patients with spinocerebellar degeneration
Scientific Title	Clinical study on effects of home exercise on patients with spinocerebellar degeneration
Scientific Title:Acronym	Effects of home exercise on patients with spinocerebellar degeneration
Region	Japan

Condition
Condition	Spinocerebellar Degeneration
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Spinocerebellar degeneration (SCD) is a generic term for neurological disorders whose main symptom is cerebellar ataxia. Daily living behavior (ADL) is markedly impaired as symptoms progress. Regarding the effect of rehabilitation (rehabilitation), it has been reported that improvements in cerebellar ataxia ataxia evaluation and walking have been observed by short-term intensive rehabilitation and home exercise (Home ex.). However, these reports have verified effects of comparatively long interventions focusing on overall ataxia and gait, and effects on upper limb function and ADL has yet to be clarified. Therefore, the purpose of this study is to verify effects of Home ex. for a short time specialized in "upper limb function and ADL" for SCD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scale for the assessment and rating of ataxia. Evaluate before intervention (start of intervention, 4 weeks) and after intervention (8 weeks).
Key secondary outcomes	9-Hole Peg Test Functional Independence Measure Beck Depression Inventory-Second Edition SF8 Health Survey Evaluate before intervention (start of intervention, 4 weeks) and after intervention (8 weeks).

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	Behavior,custom
Interventions/Control_1	The content of exercise intervention is 4 weeks Home ex. The contents of that will be repeatedly conducted ADL action guidance that the subject is struggling with at home. Home ex. Is carried out for 20 minutes / times 5 days a week 4 weeks
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases present spinocerebellar degeneration and can be done Home.ex.
Key exclusion criteria	Cases show a decline in prominent cognitive function and can not be done Home.ex.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Takehito Middle name Last name YONEZAWA
Organization	Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name	Department of Community-based Rehabilitation Sciences
Zip code	852-8511
Address	1-7-1, Sakamoto, Nagasaki, Japan
TEL	095-819-7904
Email	mikemizuno@hotmail.com

Public contact
Name of contact person	1st name Takehito Middle name Last name YONEZAWA
Organization	Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name	Department of Community-based Rehabilitation Sciences
Zip code	852-8511
Address	1-7-1, Sakamoto, Nagasaki, Japan
TEL	095-819-7904
Homepage URL
Email	mikemizuno@hotmail.com

Sponsor
Institute	Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Institute
Department

Funding Source
Organization	Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
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	Nagasaki University Graduate School of Biomedical Sciences
Address	1-12-4 sakamoto-mati, nagasaki-si, nagasaki-ken
Tel	095-819-7195
Email	gakujutu_kikaku@ml.nagasaki-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	2018 Year 03 Month 25 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	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 05 Month 17 Day
Anticipated trial start date	2018 Year 05 Month 17 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 09 Month 07 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 25 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029492

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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