UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050310 |
|---|---|
| Receipt number | R000057287 |
| Scientific Title | Validation of paralyzed side upper limb activity according to upper limb function level in acute stroke patients |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2024/02/18 15:29:10 |
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Basic information
Public title
Validation of paralyzed side upper limb activity according to upper limb function level in acute stroke patients
Acronym
Validation of paralyzed side upper limb activity according to upper limb function level in acute stroke patients
Scientific Title
Validation of paralyzed side upper limb activity according to upper limb function level in acute stroke patients
Scientific Title:Acronym
Validation of paralyzed side upper limb activity according to upper limb function level in acute stroke patients
Region
| Japan |
Condition
Condition
A first-onset acute case of cerebral hemorrhage or cerebral infarction for which occupational therapy was prescribed
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the upper limb activity of the paralyzed side in patients with first-ever acute stroke by classifying the upper limb function into 5 levels using the Action Research Arm Test and measuring the upper limb activity for 2 consecutive weeks.
Basic objectives2
Others
Basic objectives -Others
To examine the differences in recovery of paralytic upper limb activity in five levels of paralytic upper limb severity.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
It will be administered to patients who meet the indication criteria within 7days of the occupational therapy prescription for acute stroke patients. It will then be administered again 14days later as a reassessment.
Assessment Item: Action Research Arm Test
Details: ARAT is a post-stroke upper limb motor function assessment method developed based on the Upper Extremity Function Test (Ohba et al., 2011). There are 19 items in total consisting of 4 subtests (Grasp: grasp, Grip: grip, Pinch: pinch, Gross movement: gross movement), and the total score consists of 57 points. The score is weighted from 0 to 57 if there is no paralytic upper limb dysfunction, and from 0 to 57 if there is significant paralytic upper limb dysfunction. The evaluation method is based on the movement of objects on the desk under various conditions.
Key secondary outcomes
Activity meters will be attached to both upper limbs from the day after the completion of the Action Research Arm Test, the initial evaluation, and upper limb activity will be measured for 14 consecutive days.
Upper limb activity meter: Actigraph (wGT3X-BT, GT3XPBT): Evaluation scale of upper limb activity
The device is a lightweight wristwatch-type device equipped with triaxial sensors placed on the back of the wrist joints of both upper limbs, and enables detailed evaluation of the direction of movement.
In the rehabilitation field, the device has been used to analyze upper limb activity and other limb and trunk activities. In addition to stroke patients, the device has been used to study the whole-body activity of patients with arthritis, central nervous system diseases, chronic obstructive pulmonary disease, neuromuscular diseases, and Parkinson's disease, and can accurately and safely measure them.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cerebral hemorrhage or cerebral infarction for whom occupational therapy is prescribed.
Patients with cerebrovascular disease who are undergoing rehabilitation within 1 week from the onset of the disease.
Patients over 20 years old.
Patients who score 2 or less on the sensory items of the National Institutes of Health Stroke Scale (NIHSS).
Patients with a score of 24 or more on the Mini Mental State Examination-Japanese.
Patients who were independent in Activity of Daily of Living (ADL) (Barthel Index: 95 points or more) before the onset of the disease.
No history of orthopedic disease in the paralyzed upper limb.
Patient's written consent is obtained.
Key exclusion criteria
Patients with a history of prior stroke.
Patients who have difficulty in understanding the rating scale due to cognitive decline.
Patients who have difficulty in verbal expression.
Patients with neurological or neuropsychological worsening of symptoms during the observation period.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | kouda |
| Middle name | |
| Last name | tsuyoshi |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation Center
Zip code
350-1298
Address
saitama,hidakacity,yamane 1397-1
TEL
042-984-4177
tuyo-tuba.k0104@outlook.jp
Public contact
Name of contact person
| 1st name | kouda |
| Middle name | |
| Last name | tsuyoshi |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation Center
Zip code
350-1298
Address
saitama,hidakacity,yamane 1397-1
TEL
042-984-4177
Homepage URL
tuyo-tuba.k0104@outlook.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center
Address
saitama,hidakacity,yamane 1397-1
Tel
042-984-4177
tuyo-tuba.k0104@outlook.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
| 2023 | Year | 02 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: longitudinal observational study
Measurement period: January 20, 2023 - March 31, 2024
Management information
Registered date
| 2023 | Year | 02 | Month | 12 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057287
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