UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the intensive task-oriented approach of affected upper limbs for unilateral spatial neglect in stroke patient.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takashi Takebayashi
Organization	Kibi International university
Division name	School of health science and social welfare
Address	Iga 8, Takahashi, Okayama
TEL	0866-22-9894
Email	takshi77@gmail.com

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

Sponsor
Institute	Kibi international university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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