UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the self-monitoring of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke: a randomized controlled trial
Title of the study (Brief title)	Effect of the self-monitoring on physical activity in patients with ischemic stroke
Region	Japan

Condition
Condition	Ischemic stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the self-monitoring of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hospitalized physical activity
Key secondary outcomes	Exercise energy expenditure Duration of activity time Self-efficacy for physical activity Stroke recurrence Other cardiovascular event Post-discharge physical activity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Self-monitoring group: rehabilitation combined with a directed self-monitoring approach
Interventions/Control_2	Control group: rehabilitation
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	Not applicable
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Acute ischemic stroke patients who could walk without assistance within 1 week of admission.
Key exclusion criteria	Patients with aphasia, visual field defect, dementia, age > 80 years old, premorbid modified Rankin Scale score > 2, psychiatric disease and patient refusal to participate in the study.
Target sample size	66

Research contact person
Name of lead principal investigator	Shinichi Shimada
Organization	Itami Kousei Neurosurgical Hospital
Division name	Department of Neurosurgery
Address	1-300-1, Nishino, Itami-shi, Hyogo
TEL	072-781-6600
Email	shimada_s@itami-kousei.jp

Public contact
Name of contact person	Masashi Kanai
Organization	Itami Kousei Neurosurgical Hospital
Division name	Department of Rehabilitation
Address	1-300-1, Nishino, Itami-shi, Hyogo
TEL	072-781-6600
Homepage URL
Email	kanaima-c07@umin.ac.jp

Sponsor
Institute	Department of Rehabilitation, Itami Kousei Neurosurgical Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	伊丹恒生脳神経外科病院

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 12 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 15 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 11 Month 15 Day
Date trial data considered complete	2017 Year 11 Month 30 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 12 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033296