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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022658
Receipt No. R000025987
Scientific Title The effect of the intensive task-oriented approach of affected upper limbs for unilateral spatial neglect in stroke patient.
Date of disclosure of the study information 2016/06/08
Last modified on 2016/06/08

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Basic information
Public title The effect of the intensive task-oriented approach of affected upper limbs for unilateral spatial neglect in stroke patient.
Acronym The effect of intensive task-oriented approach of affected upper limbs for unilateral spatial neglect.
Scientific Title The effect of the intensive task-oriented approach of affected upper limbs for unilateral spatial neglect in stroke patient.
Scientific Title:Acronym The effect of intensive task-oriented approach of affected upper limbs for unilateral spatial neglect.
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, there are the several approaches for USN. For typically approach, there is visual searching training. This approach creates awareness to attention to neglect space by simulating patients to actively search targets in neglect space. Several researchers showed that this approaches improved significant outcome of USN in tests of visual searching, and activities of daily living. On the other hand, Limb activation training is also famous approach for USN. This approach creates awareness to attention to neglect space by simulating patients to actively use patients' upper limbs of neglect side. Several researchers showed that this approaches also improved significant outcome of USN in tests of visual searching, and activities of daily living. Previously, Luukkainen-Markkula, et al,. compared the different for USN between visual searching training and limb activation training. In this study, for test of visual searching (Behavioral Inattention Test (BIT)), both approaches significantly improved for short, and long-term period. However, for Catherine bergego scale, limb activation training significantly improved USN not only for short-term period but also for long-term period. By contract, visual searching training significantly improved USN for short-term, although long-term benefit is not significant improvement.
Generally, BIT is measurement that mainly be influenced from the actively attention. On other hand, CBS is measurement that is influenced from both actively and passively attention. In our study, we investigated whether the task-oriented training (one of the limb activation) influence actively or passively attention using @Attention (Attention is a devise that able to assess the actively and passively attention in USN patients).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The response time in passively attention test using @Attention.
Key secondary outcomes The response time in actively attention test using @Attention.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention time is one task-oriented training session. One session consist of 60 minutes. Intervention is limb activation training. In this study, limb activation training consists of shaping, and task practice in constraint-induced movement therapy.
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria In all study, inclusion criteria: participants are primary acute or sub-acute (one month to 6month from onset stroke) stroke patients who be able to extent at least 1 degree at each of finger joints.

Study 1: Participants are primary stroke patients without USN (Patients have no problem in test of star canceller, line bisection task, red aloud task, Ogden Copy task, and Clock drawing test). Participants' time from onset stroke is from a month to 6months.

Study2: Participants are primary stroke patients with USN (Patients have any problem in test of star canceller, line bisection task, red aloud task, Ogden Copy task, and Clock drawing test). Participants' time from onset stroke is from a month to 6months.
Key exclusion criteria Exclusion criteria: Patients have apraxia, aphasia, and severe cognitive probrem, who are not able to understand about explain of evaluation.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Takebayashi
Organization Kibi International university
Division name School of health science and social welfare
Zip code
Address Iga 8, Takahashi, Okayama
TEL 0866-22-9894
Email takshi77@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Takebayashi
Organization Kibi International university
Division name School of health science and social welfare
Zip code
Address Iga 8, Takahashi, Okayama
TEL 0866-22-9894
Homepage URL
Email takshi77@gmail.com

Sponsor
Institute Kibi international university
Institute
Department

Funding Source
Organization non
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
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
2016 Year 06 Month 08 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 08 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
2016 Year 06 Month 08 Day
Last modified on
2016 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025987

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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