UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016716 |
|---|---|
| Receipt number | R000019395 |
| Scientific Title | Effect of fall prevention education programs for patients in convalescent phase after stroke: a randomized controlled trial. |
| Date of disclosure of the study information | 2015/03/05 |
| Last modified on | 2022/09/09 11:05:27 |
* 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
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
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
iimtptkta@yahoo.co.jp
Sponsor or person
Institute
International institute of medical therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019395
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
