UMIN-CTR Clinical Trial

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

cerebral vascular disease

Classification by specialty

Neurosurgery	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Kibi International University

Institute

Department

Personal name

Organization

Kibi International University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

河野脳神経外科病院（大分県）
Kawano Neurosurgical Hospital (Oita)

Date of disclosure of the study information

2016

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

10

Month

30

Day

Last modified on

2018

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028340