UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003289 |
|---|---|
| Receipt number | R000003981 |
| Scientific Title | The efficacy of rehabilitation for patients with cognitive impairment |
| Date of disclosure of the study information | 2010/03/05 |
| Last modified on | 2010/10/05 10:06:06 |
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Basic information
Public title
The efficacy of rehabilitation for
patients with cognitive impairment
Acronym
Cognitive rehabilitation
Scientific Title
The efficacy of rehabilitation for
patients with cognitive impairment
Scientific Title:Acronym
Cognitive rehabilitation
Region
| Japan |
Condition
Condition
Patients with barin injury
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of cognitive rehabilitation for patients with brain injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE (Mini-Mental State Examination)
TMT A&B (Trail Making Test A&B)
CAT (Clinical Assessment for Attention)
BADS (Behavioural Assessment of the Dysexecutive Syndrome)
FIM & FAM (Functional Indipendence Measure, Functional Assessment Measure)
RSE (Rosenberg Self-Esteem scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive training PC version (once a week, 45-60min/session, 10 sessions)
Interventions/Control_2
Cognitive training text version (once a week, 45-60min/session, 10 sessions)
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with cognitive impairment
(They have a note from their doctor)
Key exclusion criteria
Patients with
1) mental retardation
2) persistent disturbance of consciousness
3) psychoactive substance or alchol dependence
4) dementia
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Mitani |
Organization
Kyoto University
Division name
Lab. of Neurorehabilitation
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3913
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Department of Human Health Sciences, Graduate School of Medicine
Zip code
Address
TEL
075-751-3913
Homepage URL
Sponsor or person
Institute
Department of Human Health Sciences,
Graduate School of Medicine,
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 03 | Month | 05 | 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
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
| 2010 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 04 | Day |
Last modified on
| 2010 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003981
