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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 | UMIN000046272 |
Receipt No. | R000052790 |
Scientific Title | Long-Term Effects of Intensive Language Training for ataxic dysarthria |
Date of disclosure of the study information | 2022/01/15 |
Last modified on | 2022/06/03 |
Basic information | ||
Public title | Long-Term Effects of Intensive Language Training for ataxic dysarthria | |
Acronym | Long-Term Effects of Intensive Language Training for ataxic dysarthria | |
Scientific Title | Long-Term Effects of Intensive Language Training for ataxic dysarthria | |
Scientific Title:Acronym | Long-Term Effects of Intensive Language Training for ataxic dysarthria | |
Region |
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Condition | |||
Condition | cortical cerebellar atrophy CCA
multiple system atrophy MSA |
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Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study was to evaluate the long-term effects of a 4-week rehabilitation program for patients with SCD.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1) Scale for the assessment and Rating of Ataxia :SARA
2) Speech intelligibility and naturalness 3) Maximum Phonation Time 4) Oral Diadochokinesis ODK 5) Speech rate 6) Acoustic Analysis |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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 who participated in our intensive SCD program | |||
Key exclusion criteria | 1) Minors
2) Persons with missing data |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Center of Neurology and Psychiatry | ||||||
Division name | Department of Rehabilitaion | ||||||
Zip code | 1878551 | ||||||
Address | 4-1-1, Ogawa higashi, Kodaira ,Tokyo | ||||||
TEL | 0423412711 | ||||||
stnakayama@ncnp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Center of Neurology and Psychiatry | ||||||
Division name | Department of Rehabilitation | ||||||
Zip code | 1878551 | ||||||
Address | 4-1-1, Ogawa higashi, Kodaira ,Tokyo | ||||||
TEL | 0423412711 | ||||||
Homepage URL | |||||||
stnakayama@ncnp.go.jp |
Sponsor | |
Institute | National Center of Neurology and Psychiatry |
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 | National Center of Neurology and Psychiatry |
Address | 4-1-1, Ogawa higashi, Kodaira ,Tokyo |
Tel | 0423412711 |
rinri-jimu@ncnp.go.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 | Partially published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 31 |
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 |
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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 |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information | Conduct a backward-looking observational study of patients admitted to our hospital for the SCD Intensive Rehabilitation Program to evaluate them before, during and after the program.
Subject evaluation and statistical analysis have been completed and data compilation is currently underway. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052790 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |