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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Spinocerebellar Degeneration | |
Classification by specialty |
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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 |
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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 |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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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 |
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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 | |
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Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |