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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029120
Receipt No. R000033296
Scientific Title Effect of the self-monitoring of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke: a randomized controlled trial
Date of disclosure of the study information 2017/09/12
Last modified on 2017/09/12

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Basic information
Public title Effect of the self-monitoring of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke: a randomized controlled trial
Acronym Effect of the self-monitoring on physical activity in patients with ischemic stroke
Scientific Title Effect of the self-monitoring of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke: a randomized controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Shinichi Shimada
Organization Itami Kousei Neurosurgical Hospital
Division name Department of Neurosurgery
Zip code
Address 1-300-1, Nishino, Itami-shi, Hyogo
TEL 072-781-6600
Email shimada_s@itami-kousei.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kanai
Organization Itami Kousei Neurosurgical Hospital
Division name Department of Rehabilitation
Zip code
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)

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 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

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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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