UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052690 |
|---|---|
| Receipt number | R000059977 |
| Scientific Title | Efficacy and safety of frequent mobilization in acute stroke patients: A single center retrospective non-randomized controlled study |
| Date of disclosure of the study information | 2023/11/02 |
| Last modified on | 2023/11/02 21:26:23 |
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Basic information
Public title
Efficacy and safety of frequent mobilization in acute stroke patients: A single center retrospective non-randomized controlled study
Acronym
Efficacy and safety of frequent mobilization in acute stroke patients
Scientific Title
Efficacy and safety of frequent mobilization in acute stroke patients: A single center retrospective non-randomized controlled study
Scientific Title:Acronym
Efficacy and safety of frequent mobilization in acute stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of early mobilization for stroke patients have been widely reported and recommended in several guidelines. The optimal frequency and duration of early mobilization are unknown, although it is believed that 24 to 48 hours after onset of stroke is desirable. On the other hand, the AVERT study reported that frequent mobilization contributes to improved functional outcome. Therefore, our hospital has started frequent bed-withdrawal within 48 hours of onset of illness. In this study, we compared the efficacy and safety of frequent mobilization before and after the introduction of frequent mobilization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy outcomes were the Functional Ambulation Categories (FAC) and the modified-Rankin Scale (mRS), and immobility-related complications at 3 months after stroke onset, with FAC as a measure of walking ability and mRS as a measure of independence in activities of daily living. FAC and mRS are used as functional prognostic measures for stroke patients. Safety outcomes were the presence of neurological adverse events and death during hospitalization.
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients were defined as acute stroke patients admitted to Kansai electric power Hospital from August 2015 to December 2019.
Key exclusion criteria
Subarachnoid hemorrhage, infratentorial lesion, ventilator management, mRS greater than 4 before onset, palliative care, patients undergoing dialysis, surgically treated cases, and patients who met our discontinuation criteria for early mobilization were excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Watanabe |
Organization
Kansai electric power hospital
Division name
department of rehabilitation
Zip code
553-0003
Address
2-1-7, Fukushima, Fukushima-ku, Osaka-shi, Osaka
TEL
06-6458-5821
koki04271007@gmail.com
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Watanabe |
Organization
Kansai electric power hospital
Division name
department of rehabilitation
Zip code
553-0003
Address
2-1-7, Fukushima, Fukushima-ku, Osaka-shi, Osaka
TEL
06-6458-5821
Homepage URL
koki04271007@gmail.com
Sponsor or person
Institute
Kansai electric power hospital
Institute
Department
Personal name
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
Kansai electric power hospital
Address
2-1-7, Fukushima, Fukushima-ku, Osaka-shi, Osaka
Tel
06-6458-5821
koki04271007@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
| 2023 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
https://kanden-hsp.jp/patient/oshirase/rehabilitation_19.pdf
Publication of results
Partially published
Result
URL related to results and publications
http://jsnpt20.umin.jp/images/gene_abstractbook.pdf
Number of participants that the trial has enrolled
401
Results
The number of subjects analyzed was 121 in the HF group and 93 in the control group. The difference between the two groups was significant (p<0.05). The number of patients with FAC > 2 at discharge was 106 (87%) in the HF group and 69 (74%) in the control group, significantly more in the HF group (p<0.05). Immobility-related complications and neurological adverse events were not significantly different between the two groups.
Results date posted
| 2023 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects (control and high-frequency groups) were age (71.2, 68.2years), gender (59 males/34 females; 78 males/43 females), disease type (75 cerebral infarction/18 cerebral hemorrhage; 99 cerebral infarction/22 cerebral hemorrhage), NIHSS 1-7 (77, 103), NIHSS8-16 (11, 17), and NIHSS16-42 (5, 1).
Participant flow
Acute stroke patients admitted between August 2015 and December 2019 were included. A total of 401 individuals were eligible during the study period. Excluding 187 of them who met the exclusion or discontinuation criteria, 214 patients (121 in the high-frequency group and 93 in the control group) were eligible for analysis.
Adverse events
Adverse events were defined as the presence or absence of neurological adverse events, which were defined as recurrent stroke, worsening of neurological symptoms, or death. Neurological adverse events occurred in 4 of 121 patients in the HF group and 2 of 93 patients in the control group, with no significant difference between the two groups.
Outcome measures
The primary outcome measures were immobility-related complications (pneumonia, urinary tract infection, deep vein thrombosis, pulmonary embolism, bedsores, and depression), Functional Ambulation Categories at discharge, modified-Rankin Scale at discharge, and neurological adverse events. As secondary items, time from onset to start of standing, frequency of rehabilitation from onset to 14 days, rehabilitation time from onset to 14 days, and rehabilitation time per day were investigated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 29 | Day |
Other
Other related information
This is a single-center, retrospective, observational study.
Acute stroke patients admitted to KEPCO Hospital from August 2015 to December 2019 were included. Diagnosis, comorbidity, age, gender, NIHSS, FAC, ABMS II, rehabilitation intervention time, frequency, number of days until acquisition of end seating position, hospital stay, destination, complications, mRS, disease type, lesion site, lesion side, tPA status, and Barthel Index were investigated.
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059977
