UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019408 |
|---|---|
| Receipt number | R000022390 |
| Scientific Title | Flow experience during attentional training improves cognitive functions in patients with traumatic brain injury: a randomized controlled trial |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2017/10/23 11:49:22 |
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Basic information
Public title
Flow experience during attentional training improves cognitive functions in patients with traumatic brain injury: a randomized controlled trial
Acronym
Flow experience during attentional training improves cognitive functions in patients with traumatic brain injury: a randomized controlled trial
Scientific Title
Flow experience during attentional training improves cognitive functions in patients with traumatic brain injury: a randomized controlled trial
Scientific Title:Acronym
Flow experience during attentional training improves cognitive functions in patients with traumatic brain injury: a randomized controlled trial
Region
| Japan |
Condition
Condition
Traumatic brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to examine whether flow experience facilitates the effects of attention training for patients with traumatic brain injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Moss attention rating scale (MARS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
We created two types of video game tasks for attentional training; one is a flow task and the other is a control task. These tasks had identical content, except that the flow task
was designed to induce flow by balancing levels of skill and
challenge and giving quick feedback about the score. Patients perform 40 sessions (20 minutes in each settion) for a month.
Interventions/Control_2
The control task maintained a constant level of task difficulty regardless of the patient's skill and did not provide feedback about the score. Patients perform 40 sessions (20 minutes in each settion) for a month.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will recruit patients with attention deficits after traumatic brain injury. We check whether patients have attention deficits or not by using neuropsychological test.
Key exclusion criteria
Patients who have any history of developmental disorder, psychiatric disorder, or other neurological diseases other than TBI. Patients who have comprehension deficits or severe
aphasia.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikoma Katsunori |
Organization
Hokkaido university hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
N14 W5, Kita-ku, Sapporo
TEL
011-706-6066
ikoma@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshida Kazuki |
Organization
Hokkaido university
Division name
Department of rehabilitation
Zip code
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
handballer610@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Functioning and Disability, Faculty of Health Sciences, Hokkaido University
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
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 | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2017 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022390
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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