UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035433 |
|---|---|
| Receipt number | R000040362 |
| Scientific Title | Predictors of long-term effects using tensor images in Constraint-induced movement therapy (CIMT) |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2023/01/10 15:32:31 |
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Basic information
Public title
Predictors of long-term effects using tensor images in Constraint-induced movement therapy (CIMT)
Acronym
Predictors of long-term effects In CIMT(A tensor imaging study)
Scientific Title
Predictors of long-term effects using tensor images in Constraint-induced movement therapy (CIMT)
Scientific Title:Acronym
Predictors of long-term effects In CIMT(A tensor imaging study)
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze predictors of long-term effectives in CIMT using by tensor imaging
Basic objectives2
Others
Basic objectives -Others
Mechanism of the effect by CIMT
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
delta-FMA
Key secondary outcomes
delta-ARAT, delta-WMFT, delta-MAL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
CIMT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We enrolled patients with chronic stroke (>7 months from stroke onset) who received CIMT as outpatients at the Hyogo College of Medicine Hospital
Key exclusion criteria
Exclusion criteria were as follows: severe balance or walking disorders as indicated by the need for assistance in any ADL; substantial use of the affected upper extremity before CIMT, as indicated by a score >2.5 points on the Amount of Use (AOU) scale of the Motor Activity Log (MAL); dementia or cognitive disorders, as indicated by a Mini-Mental State Examination score <24 points; severe aphasia or apraxia inhibiting CIMT performance; the presence of another uncontrolled medical condition or severe end-stage disease; severe contraction around upper extremity joints; the absence of pre-CIMT magnetic resonance imaging
(MRI) data; missing clinical assessment data from any follow-up time point; and receiving any other rehabilitation intervention for the affected upper extremity after CIMT.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL
+81-(798)45-6881
k.maru5081@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Marumoto |
Organization
Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Division name
Department of Physical Medicine and Rehabilitation
Zip code
679-5165
Address
1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo, Japan679-5165
TEL
+81-(791)58-1050
Homepage URL
k.maru5081@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
Tel
+81-(798)45-6881
k.maru5081@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
| 2019 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
20
Results
Strong positive correlation was found only between F-M after CIMT and PLIC-rFA (r = 0.8098, p = 0.0004).These data support PLIC-rFA as a new marker of the CIMT-induced improvement in motor function.
Results date posted
| 2023 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 03 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040362
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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