UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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	Open public 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	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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.

Management information
Registered date	2021 Year 12 Month 03 Day
Last modified on	2021 Year 12 Month 03 Day

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

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