UMIN-CTR Clinical Trial

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
Institute	Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047235