UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050779 |
|---|---|
| Receipt number | R000057862 |
| Scientific Title | A multicenter prospective observational (cohort) study of upper extremity motor activity in patients with stroke to determine the effectiveness of occupational therapy and orthotics in recovering hand and forearm motion. |
| Date of disclosure of the study information | 2023/04/07 |
| Last modified on | 2025/04/07 12:23:51 |
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Basic information
Public title
A multicenter prospective observational (cohort) study of upper extremity motor activity in patients with stroke to determine the effectiveness of using occupational therapy and bracing in recovering hand and forearm motion.
Acronym
Investigation of upper limb motor activity for the effectiveness of orthotics and intensive occupational therapy to restore hand and forearm motion in patients with stroke.
Scientific Title
A multicenter prospective observational (cohort) study of upper extremity motor activity in patients with stroke to determine the effectiveness of occupational therapy and orthotics in recovering hand and forearm motion.
Scientific Title:Acronym
Investigation of upper limb motor activity for the effectiveness of intensive occupational therapy and orthotics to recovering hand and forearm motion in patients with stroke.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the amount of upper limb movement that is recovered in a clinically meaningful way when stroke patients are fitted with upper limb and finger braces and given functional exercises that promote isolated movement. The amount of upper limb movement that achieves clinically meaningful recovery will be examined.
Basic objectives2
Others
Basic objectives -Others
To investigate paraplegic recovery in patients with moderate paraplegia wearing upper extremity and hand orthoses and performing functional exercises that promote isolated movement according to the severity of paraplegia. From the upper extremity motor data and ADLs obtained, we will examine the amount of clinically meaningful functional recovery from upper extremity practice and the amount of upper extremity movement to achieve it.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Brunnstrom recovery stage
Fugl meyer assessment
Wolf Motor Function Test
Action Research Arm Test
Key secondary outcomes
EuroQual
Jikei Assessment Scale for Motor Impairment in Daily Living
Functional Independence Measure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Stroke patients with upper extremity paralysis aged 18 to 90.
2. Less than 6 months after stroke onset.
3. Patients with upper limb Brunnstrom stage III-IV, which is an evaluation of upper limb function.
4. Those who are in stable general condition.
5. Able to understand the research plan without cognitive impairment.
6. Patients who have been fully informed about the study and who have given written consent of their own free will based on a thorough understanding of the study.
7. Gender is not an issue.
8. The training will be limited to those who are able to follow the research implementation schedule.
Key exclusion criteria
1. Those who have fragile skin and cannot wear braces or wristwatch type activity loggers.
2. Patients with mentally anxious.
3.In addition, those who are judged inappropriate for participation in this research by the person responsible for the research(co-investigator).
4.Those who have a disease that is not stable or requires urgent treatment (acute heart failure, acute renal failure, acute liver failure, severe diabetes, infectious disease, etc.)
5.Those who have participated in other clinical trials within 4 months
6.Those who have dementia and cannot train as instructed.
7. Those who cannot perform training as instructed due to higher brain dysfunction
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Ohtaki |
Organization
Izumi Memorial Hospital
Division name
Department of Rehabilitation
Zip code
123-0853
Address
1-3-7 Motoki,Adachi Ward, Tokyo
TEL
+81-03-5888-2111
ot.naoto@gmail.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Ohtaki |
Organization
Izumi Memorial Hospital
Division name
Department of Rehabilitation
Zip code
123-0853
Address
1-3-7 Motoki,Adachi,Tokyo
TEL
+81-03-5888-2111
Homepage URL
ot.naoto@gmail.com
Sponsor or person
Institute
Izumi Memorial Hospital
Institute
Department
Personal name
Naoto Ohtaki
Funding Source
Organization
Izumi Memorial Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Health Science Saitama Prefectural University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Izenkai Ethics Revie Committee for observational studies
Address
1-3-7 Motoki,Adachi,Tokyo
Tel
+81-03-5888-2111
ot.naoto@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 | 04 | Month | 07 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
NO
Management information
Registered date
| 2023 | Year | 04 | Month | 06 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057862
