UMIN-CTR Clinical Trial

Basic information
Public title	Effect of fall prevention education programs for patients in convalescent phase after stroke: a randomized controlled trial.
Acronym	Effect of fall prevention education programs for patients in convalescent phase after stroke
Scientific Title	Effect of fall prevention education programs for patients in convalescent phase after stroke: a randomized controlled trial.
Scientific Title:Acronym	Effect of fall prevention education programs for patients in convalescent phase after stroke
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I want to verify the effects of a fall prevention program of falls risk by level of convalescent stroke patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of inpatients falling during intervention period and post- intervention period
Key secondary outcomes	Changes of falls self-efficacy scale and FIM during hospitalization.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group Usual rehabilitation program Education rehabilitation program about the risk of falls and physical activity.
Interventions/Control_2	Control group Usual rehabilitation program
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	Stroke patients admitted to Rehabilitation Hospital, has received the rehabilitation of normal. Patients who obtained consent to research.
Key exclusion criteria	Patients communication is not possible due to cognitive impairment severe. Patients who transfer means a stretcher. Patients who cannot run or awareness and understanding about the preventive measures. Patients who are hospitalized period of less than one month.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Keiji Middle name Last name Asada
Organization	Suzuka University of Medical Science
Division name	Faculty of Health Science Department of Physical Therapy
Zip code	510-0226
Address	1001-1 Kishiokacho, Suzuka city, Mie prefecture
TEL	059-383-8991
Email	iimtptkta@gmail.com

Public contact
Name of contact person	1st name Keita Middle name Last name Okada
Organization	International institute of medical therapy
Division name	Department of Rehabilitation
Zip code	510-0051
Address	3-1-46 nishiku noritakeshinmachi, Nagoya city, Aichi prefecture
TEL	052-561-1166
Homepage URL
Email	iimtptkta@yahoo.co.jp

Sponsor
Institute	International institute of medical therapy
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	Suzuka University of Medical Science
Address	1001-1 Kishiokacho, Suzuka city, Mie prefecture
Tel	059-383-8991
Email	iimtptkta@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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 05 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	0
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	Terminated
Date of protocol fixation	2014 Year 02 Month 27 Day
Date of IRB	2015 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 05 Day
Last modified on	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019395