UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024637
Receipt No. R000028340
Scientific Title 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
Date of disclosure of the study information 2016/11/01
Last modified on 2018/06/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym RCT on extra service allocation based on an assessment of needs for medical rehabilitation in acute stroke
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhiro Harada
Organization Kibi International University
Division name Faculty of Healthcare and Welfare
Zip code
Address 8 Iga-machi, Takahashi, Okayama, Japan
TEL 0866-22-9472
Email k_harada@kiui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Harada
Organization Kibi International University
Division name Faculty of Healthcare and Welfare
Zip code
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)

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 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

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
2016 Year 10 Month 06 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.