UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041374
Receipt number R000047235
Scientific Title To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation Effect of injury
Date of disclosure of the study information 2020/08/10
Last modified on 2020/08/10 13:13:40

* 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

To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury

Acronym

To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury

Scientific Title

To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury

Scientific Title:Acronym

To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury

Region

Japan


Condition

Condition

Target of rehabilitation (outpatient/outpatient/visit/gymnastic class) in our life

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of shared decision-making and motivation on the health behaviors of life-stage rehabilitation subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Basic information
Target: Age, gender, main disease name, insurance information (medical insurance, degree of long-term care)
Rehabilitation type (outpatient/outpatient/visit/gymnastic classroom)
Frequency of use (times/week), period from start of use
2.Physical function evaluation
Gait Independence: Functional Ambulation Classification of the Hospital at Sagunto
Lower limb strength: knee extension strength
3.Shared decision evaluation
Shared Decision Making for Rehabilitation
Decision Preference: Control Preference Scale
Strength of Motivation: Behavioral Regulation in Exercise Questionnaire-2
4.Exercise health evaluation
Information on the amount of physical activity in daily life
Level of understanding and adherence to self-practice

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Target of rehabilitation (outpatient/outpatient/visit/gymnastic class) in our life

Key exclusion criteria

Persons with cognitive dysfunction that makes it difficult to answer all survey items and manage physical activity

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Kousuke
Middle name
Last name Hirata

Organization

Kawaguchi Neurosurgery Rehabilitation Clinic

Division name

Department of Rehabilitation

Zip code

5730086

Address

9-25-202 Koriencho, Hirakata City, Osaka

TEL

0728351010

Email

kawaguchi.ns.reha@gmail.com


Public contact

Name of contact person

1st name Kousuke
Middle name
Last name Hirata

Organization

Kawaguchi Neurosurgery Rehabilitation Clinic

Division name

Department of Rehabilitation

Zip code

5730086

Address

9-25-202 Koriencho, Hirakata City, Osaka

TEL

0728351010

Homepage URL

https://kawaguchi-ns.com

Email

kawaguchi.ns.reha@gmail.com


Sponsor or person

Institute

Kawaguchi Neurosurgery Rehabilitation Clinic

Institute

Department

Personal name



Funding Source

Organization

None

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

Kawaguchi Neurosurgery Rehabilitation Clinic

Address

9-25-202 Koriencho, Hirakata City, Osaka

Tel

0728351010

Email

kawaguchi.ns.reha@gmail.com


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

川口脳神経外科リハビリクリニック(大阪府)、西大和リハビリテーション病院(奈良県)


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 10 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

2020 Year 07 Month 14 Day

Date of IRB

2020 Year 07 Month 14 Day

Anticipated trial start date

2020 Year 07 Month 14 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Basic information survey, physical function evaluation, and questionnaire items are surveyed during normal clinical time, and only physical activity measurements are surveyed outside normal clinical time.
A physical activity meter (HJA-750C, made by OMRON) is attached to either the left or right waist of the subject.
Continuously measure the amount of physical activity shown in daily life for 3 to 7 days (from waking up to bed except when taking a bath).


Management information

Registered date

2020 Year 08 Month 10 Day

Last modified on

2020 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name