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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031892
Receipt No. R000029492
Scientific Title Clinical study on effects of home exercise on patients with spinocerebellar degeneration
Date of disclosure of the study information 2018/03/25
Last modified on 2020/09/28

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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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