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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040079 |
Receipt No. | R000045633 |
Scientific Title | Effects of rehabilitation on cognitive dysfunction in pure cerebellar degeneration |
Date of disclosure of the study information | 2020/04/30 |
Last modified on | 2020/04/06 |
Basic information | ||
Public title | Effects of rehabilitation on cognitive dysfunction in spinocerebellar degeneration | |
Acronym | Examination of rehabilitation effect of spinocerebellar degeneration | |
Scientific Title | Effects of rehabilitation on cognitive dysfunction in pure cerebellar degeneration | |
Scientific Title:Acronym | Examination of rehabilitation effect of pure cerebellar 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 | To clarify whether rehabilitation is effective for cognitive dysfunction in spinocerebellar degeneration |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Cognitive function evaluation
Evaluate before intervention and after 4 weeks |
Key secondary outcomes |
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 | 4 weeks of rehabilitation
6 times a week 3 hours a day rehabilitation |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with spinocerebellar degeneration | |||
Key exclusion criteria | Exclusion criteria included history of stroke, depression, complications including severe infection, deep vein thrombosis, orthopedic diseases causing pain during gait, unstable angina and cardiopulmonary disease causing dyspnea during exercise, and recent history of surgical intervention, including coronary artery bypass graft. | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | kumamoto southern regional hospital | ||||||
Division name | department of rehabilitation | ||||||
Zip code | 861-4214 | ||||||
Address | mu-banchi mainohara jhonan-machi minami-ku kumamoto | ||||||
TEL | 0964-28-2555 | ||||||
sentyoukansetu@icloud.com |
Public contact | |||||||
Name of contact person |
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Organization | kumamoto southern regional hospital | ||||||
Division name | department of rehabilitation | ||||||
Zip code | 861-4214 | ||||||
Address | mu-banchi mainohara jhonan-machi minami-ku kumamoto | ||||||
TEL | 0964-28-2555 | ||||||
Homepage URL | |||||||
sentyoukansetu@icloud.com |
Sponsor | |
Institute | kumamoto southern regional hospital |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | N/A |
Address | N/A |
Tel | N/A |
N/A |
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 | Partially published |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000045633 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |