UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057876 |
|---|---|
| Receipt number | R000066154 |
| Scientific Title | Balancing Rehabilitation Dose in Acute Stroke Decision-making and Global Evaluation |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2025/05/15 15:27:25 |
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Basic information
Public title
Balancing Rehabilitation Dose in Acute Stroke Decision-making and Global Evaluation
Acronym
BRIDGE STUDY
Scientific Title
Balancing Rehabilitation Dose in Acute Stroke Decision-making and Global Evaluation
Scientific Title:Acronym
Balancing Rehabilitation Dose in Acute Stroke Decision-making and Global Evaluation
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Intensive care medicine |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the impact of early rehabilitation dosage on functional independence in patients with acute stroke. Specifically, we will (1) investigate the daily rehabilitation dose administered within the first week of hospitalization, and (2) prospectively examine how rehabilitation dose, intensity, and duration influence functional independence at 90 days post-stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
modified Rankin Scale (mRS) score at 90 days after stroke onset
Key secondary outcomes
The outcome measures of this study include the return-to-work rate, number of survival days, stroke recurrence rate, and Clinical Frailty Index (CFI) at 90 days after stroke onset. Additional outcomes include the length of hospital stay; handgrip strength and Barthel Index score at hospital discharge; in-hospital survival rate during admission; and neurological and functional assessments such as the National Institutes of Health Stroke Scale (NIHSS) score and Functional Ambulation Category (FAC). Rehabilitation-related variables assessed within the first week of admission include the intensity, frequency, and duration of rehabilitation, as well as the number of days to first mobilization. Furthermore, on day 7 after admission, the modified Rankin Scale (mRS) score, handgrip strength, and NIHSS score will be evaluated. Muscle status will be assessed using ultrasound to measure the cross-sectional area and thickness of the rectus femoris muscle. Additional physical assessments include calf circumference and nutritional status, evaluated using the Malnutrition Universal Screening Tool (MUST).
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Stroke patients (cerebral infarction or cerebral hemorrhage) expected to be hospitalized for 7 days or more
2. Age 18 years or more
3. Provision of informed consent
4. Initiation of rehabilitation by day 2 of admission
Key exclusion criteria
1. Pre-hospitalization mRS 3 or more (unable to walk even with aids)
2. Terminal care patients or those with non-curative intent
3. Patients with anticipated prolonged immobility due to trauma (e.g., multiple unstable fractures, burns, amputations)
4. Inability to communicate in Japanese
5. Explicit refusal to allow use of clinical data for research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Gifu University of Health Science
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
500-8281
Address
2-92 Higashiuzura, Gifu, 500-8281, Japan.
TEL
058-274-5001
billabonghonor@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Gifu University of Health Science
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
4600001
Address
2-92 Higashiuzura, Gifu, 500-8281, Japan.
TEL
058-274-5001
Homepage URL
billabonghonor@yahoo.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Gifu University of Health Science
Address
2-92 Higashiuzura, Gifu, 500-8281, Japan
Tel
058-274-5001
billabonghonor@yahoo.co.jp
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
| 2026 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as a prospective observational study. Following approval by the ethics committee, a total of 20 patients will be enrolled during the patient registration period (with the possibility of including more than 20 cases). Eligible patients who meet the inclusion and exclusion criteria will be registered by the study coordinating center. Upon ICU admission of a patient who meets the inclusion criteria, the principal investigator or co-investigator at each participating site will assess eligibility for the study (including confirmation of exclusion criteria). A second co-investigator, preferably different from the first, will perform a screening check to verify the accuracy of the initial assessment.
The researchers responsible for screening may include the principal investigator and co-investigators appointed at each site, regardless of their professional discipline.
For patients who meet all eligibility criteria, clinical data required for the study will be entered into a dedicated Excel sheet. A subject identification code (patient registration number) will be created using a method that is not traceable to the patient's medical record number. A separate anonymization correspondence table will be prepared and stored apart from the main database. No personally identifiable information will be included in the database.
Management information
Registered date
| 2025 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066154
