UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial with parallel design on the effects of extra service allocation based on an assessment of needs for medical rehabilitation in acute patients following stroke
Title of the study (Brief title)	RCT on extra service allocation based on an assessment of needs for medical rehabilitation in acute stroke
Region	Japan

Condition
Condition	cerebral vascular disease
Classification by specialty	Neurosurgery Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of extra service allocation based on an assessment of needs for medical rehabilitation, to improve ADL independence in acute patients following stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	-Functional independence measure (FIM) motor at discharge
Key secondary outcomes	-modified Rankin Scale (mRS) -Functional Ambulation Classification (FAC) -Brunnstrom recovery stage (BRS) -modified Ashworth scale (MAS) -Stroke Impairment Assessment Set (SIAS) motor

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The chief therapist (researcher) selects patients to be emphasized to allocate extra service, by an assessment of needs for medical rehabilitation, and supervises the case's therapists with no reason of the selection, to plus at least 40-minute intervention per week. The intervention will involve in hospital (3 weeks on average, at most 4 weeks).
Interventions/Control_2	The chief therapist (researcher) selects patients as usual to be emphasized to allocate extra service, by the severity of disturbance of consciousness, and supervises the case's therapists with no reason of the selection, to plus at least 40-minute intervention per week. The intervention will involve in hospital (3 weeks on average, at most 4 weeks).
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	- Patients with a prescription for rehabilitation after hospitalization due to cerebral vascular disease - Patients after at least 3 days from stroke onset
Key exclusion criteria	- Patients with a score of 91 on motor items of the FIM - Patients with a score of 0 on motor drift item of an affected arm or leg of National Institute of Health Stroke Scale (NIHSS) - Patients with a mRS score of 4 or 5 before stroke - Patients under the following medical conditions; an occurrence of medical emergency or in need of medical examination, rest cure, and complete nursing care
Target sample size	146

Research contact person
Name of lead principal investigator	Kazuhiro Harada
Organization	Kibi International University
Division name	Faculty of Healthcare and Welfare
Address	8 Iga-machi, Takahashi, Okayama, Japan
TEL	0866-22-9472
Email	k_harada@kiui.ac.jp

Public contact
Name of contact person	Kazuhiro Harada
Organization	Kibi International University
Division name	Faculty of Healthcare and Welfare
Address	8 Iga-machi, Takahashi, Okayama, Japan
TEL	0866-22-9472
Homepage URL
Email	k_harada@kiui.ac.jp

Sponsor
Institute	Kibi International University
Institute
Department

Funding Source
Organization	Kibi International University
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	河野脳神経外科病院（大分県） Kawano Neurosurgical Hospital (Oita)

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 06 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2018 Year 06 Month 08 Day
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 10 Month 30 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028340