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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019234
Receipt No. R000022227
Scientific Title the effects of cognitive rehabilitation for vascular dementia:a randomized controlled trial.
Date of disclosure of the study information 2015/10/05
Last modified on 2016/08/22

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Basic information
Public title the effects of cognitive rehabilitation for vascular dementia:a randomized controlled trial.
Acronym the effects of cognitive rehabilitation for vascular dementia:a randomized controlled trial.
Scientific Title the effects of cognitive rehabilitation for vascular dementia:a randomized controlled trial.
Scientific Title:Acronym the effects of cognitive rehabilitation for vascular dementia:a randomized controlled trial.
Region
Japan

Condition
Condition vascular dementia
Classification by specialty
Neurology Geriatrics Psychiatry
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 verifying the effects of cognitive rehabilitation for vascular dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mini Mental State Examination(MMSE)

Key secondary outcomes Alzheimer's Disease Assessment Scale-cognitive sub scale (ADAS-cog)
Dementia Bhavior Disturbance Scale (DBD)
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Function Independence Measure (FIM)
Short version of Quality of Life Questionnaire for Dementia (short QOL-D)
Vitarity Index (VI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 conventional inpatient rehabilitation and additional cognitive rehabilitation(40 min 2 sets) 5 times a week over 8 weeks.
Interventions/Control_2 conventional inpatient rehabilitation
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.they meet ICD-10 criteria for vascular dementia.
2.They score between 10 to 23 on the mini mental state examination.
3.They take conventional inpatient speech-language therapy.
Key exclusion criteria 1.Sever aphasia
2.Disterbance of consciouness
3.Sever visual impairment
4.Sever hearing impairment

Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Mori
Organization Tokyo Bay Rehabilitation Hospital
Division name Rehabilitation
Zip code
Address 4-1-1 Yatsu,Narashino-shi,Chiba
TEL 0474539000
Email kionarimomd@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Mori
Organization Tokyo Bay Rehabilitation Hospital
Division name Rehabilitation
Zip code
Address 4-1-1 Yatsu,Narashino-shi,Chiba
TEL 0474539000
Homepage URL
Email kionarimomd@gmail.com

Sponsor
Institute Tokyo Bay Rehabilitation 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
Address
Tel
Email

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
2015 Year 10 Month 05 Day

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
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
2015 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 05 Day
Last modified on
2016 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022227

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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