UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031892 |
|---|---|
| Receipt number | 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 19:21:41 |
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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
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
mikemizuno@hotmail.com
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029492
