UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057630 |
|---|---|
| Receipt number | R000065841 |
| Scientific Title | Acute Lifting Program for Stroke with BMI (ALPS-BMI) Study |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2025/04/16 14:22:05 |
* 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
Acute Lifting Program for Stroke with BMI (ALPS-BMI) Study
Acronym
ALPS-BMI
Scientific Title
Acute Lifting Program for Stroke with BMI (ALPS-BMI) Study
Scientific Title:Acronym
ALPS-BMI
Region
| Japan |
Condition
Condition
Ischemic stroke, intracerebral hemorrhage
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to clarify the following issues:
1) therapeutic effects of BMI in acute stroke patients
2) stroke subtypes and locations of injury for which BMI is effective
3) predictors of patients' characteristics for which BMI is effective
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
FMA_UE (Fugel-Meyer assessment - upper extremity motor score) at 56 days after the start of BMI
Key secondary outcomes
1) 10-point sensory evaluation
2) MAL (Motor activity log)
3) Upper limb EMG and video evaluation
4) Upper extremity MEP (motor evoked potential)
5) EQ-5D (EuroQol 5-dimensions)
6) Diffusion tensor image (diffusion tensor image; DTI)
7) EEG evaluation during BMI training
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration of treatment: In addition to the usual rehabilitation, BMI treatment using a medical BMI device (hand type) will be performed 20 times for 30 days after enrollment. Thereafter, the patient will again undergo the usual rehabilitation required.
Observation period: 56 days after enrollment. The effect of BMI treatment will be evaluated at four time points: pre-intervention, 14 days post-intervention (interim), 28 days post-intervention (post-intervention), and 56 days post-intervention (follow-up).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included in this study
(1) Patients 18 years of age or older
(2) Patients within 7 days of stroke (cerebral infarction, cerebral hemorrhage)
(3) Patients with upper limb paralysis due to stroke
(4) Patients with an FMA-UE (Fugel-Meyer assessment - upper extremity motor score) of less than 20 points and a score of 0 or 1 for group extension in the FMA C item at the time of initial evaluation
(5) Patients who have given their written consent to participate in this clinical study.
Key exclusion criteria
Patients who meet any of the following criteria will not be included in this study
(1) Patients with a pacemaker or implantable cardioverter-defibrillator
(2) Patients who were participating in other clinical trials prior to study entry
(3) Patients who failed to complete the initial BMI training
(4) Patients deemed ineligible by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
Toyama University Hospital
Division name
Neurosurgery
Zip code
930-0194
Address
2630 Sugitani, Toyama 930-0194, Japan
TEL
076-434-7348
skuroda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
Toyama University Hospital
Division name
Neurosurgery
Zip code
930-0194
Address
2630 Sugitani, Toyama 930-0194, Japan
TEL
076-434-7348
Homepage URL
skuroda@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
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
IRB
Address
2630 Sugitani, Toyama 930-0194, Japan
Tel
076-434-7348
skuroda@med.u-toyama.ac.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
| 2025 | Year | 04 | Month | 21 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065841
