UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046272 |
|---|---|
| Receipt number | 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 | 2023/12/04 21:29:42 |
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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
| Japan |
Condition
Condition
cortical cerebellar atrophy CCA
multiple system atrophy MSA
Classification by specialty
| Neurology | Rehabilitation medicine |
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.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Nakayama |
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
| 1st name | Keigo |
| Middle name | |
| Last name | Nakayama |
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 or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
| 2022 | Year | 01 | Month | 15 | Day |
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
| Delay expected |
Results Delay Reason
Due to a backlog of submissions to the paper
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
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.
The subject evaluation and statistical analysis have been completed and the paper is currently being submitted for publication.
Management information
Registered date
| 2021 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
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 |
