UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036811 |
|---|---|
| Receipt number | R000041941 |
| Scientific Title | Diffusion tensor imaging study of stroke patients with upper limb paralysis. -the relationships between clinical functional changes and fractional anisotropy- |
| Date of disclosure of the study information | 2019/05/21 |
| Last modified on | 2025/02/28 15:28:24 |
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Basic information
Public title
Diffusion tensor imaging study of stroke patients with upper limb paralysis.
-the relationships between clinical functional changes and fractional anisotropy-
Acronym
Diffusion tensor imaging study of stroke patients with upper limb paralysis.
-the relationships between clinical functional changes and fractional anisotropy-
Scientific Title
Diffusion tensor imaging study of stroke patients with upper limb paralysis.
-the relationships between clinical functional changes and fractional anisotropy-
Scientific Title:Acronym
Diffusion tensor imaging study of stroke patients with upper limb paralysis.
-the relationships between clinical functional changes and fractional anisotropy-
Region
| Japan |
Condition
Condition
stroke
healthy control
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the changes in FA value of stroke patients with upper limb paralysis at the start of the rehabilitation and analysis of the relationships between recovery of upper limb functions and the changes in FA value after the rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fractional anisotropy value of Healthy control (after informed consent) and patients (at admission and 6 weeks later)
Key secondary outcomes
Listed assessments of patients at admission and 6 weeks later.
<Impairment assessment of U/E>
1.Fugl-Meyer Assessment(FMA) : U/E
2.Brunnstrom Stage (BS) : U/E, finger
3.STEF : All item
<Functional assessment of U/E>
4.Functional Independence Measure (FIM) : all 18 items
5.Motor Activity Log (MAL) : 14 items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects undergo a medical examination by a neurologist and DTI.
Interventions/Control_2
Subjects undergo a standard rehabilitation (physical therapy, occupational therapy, speech therapy) for six weeks. Subjects undergo DTI before and after rehabilitation, and occupational therapists evaluate upper limb and ADL functions at the same time.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Patients>
1.Clinically incipient supratentorial stroke patients with upper-limb hemiplegia
2.Patients who experienced a stroke within 6 months
3.Mini Mental State Examination>=24
4.ADL before onset was independent
5.Dextrality
6.No contraindication to magnetic resonance imaging
<Normal Controls>
1.Dextrality
2.Mini Mental State Examination>=24, result of Trail Making Test-Japan is no abnormality
3.Living everyday life without any problems, even if there is a risk factor for cerebrovascular disease (e.g.hypertension and diabetes mellitus)
4.No contraindication to magnetic resonance imaging
5.No history of cerebrovascular disease, traumatic brain injury and dementia
6.No neurological symptoms (no paretic symptoms and no hyperactive deep tendon reflex)
Key exclusion criteria
<Patients>
1.Severe aphasia
2.Cause other neuromuscular complications
3.Undergo surgical treatments
4.Consciousness disorders, psychiatric disorders
5.Having obvious neurological symptoms
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Anmoto |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
ot-dep@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Anmoto |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
ot-dep@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.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
名古屋市総合リハビリテーション事業団(愛知県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
18
Results
Both FMA and MAL showed significant changes before and after intervention (FMA-UE: p=0.001; MAL: p=0.008). The areas of each region of interest with significant pre- and post-intervention reductions in FA were the injured lateral internal hindpaw (p=0.035), the injured lateral hippocampal cingulate bundle (p=0.008), and the non-injured lateral hippocampal cingulate bundle (p=0.038).
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
The intervention was performed on 18 subjects who met the indication criteria, and all subjects were analyzed.
Adverse events
none
Outcome measures
The regions of interest with significant reductions in FA before and after intervention in each region of interest were the injured lateral internal hindpaw (p=0.035), the injured lateral hippocampal cingulate bundle (p=0.008), and the non-injured lateral hippocampal cingulate bundle (p=0.038). The correlation between upper limb function and the amount of change in each FA was not observed in the FMA, but tended to correlate in the injured side of the cingulate bundle in the MAL (r=0.441, p=0.067). As a subanalysis, in the population that corresponded to moderate to severe upper limb paralysis (n=11), no correlation was found in the FMA, but correlations were found in the brain arch (r=0.699, p=0.017) and the posterior leg of the internal capsule on the damaged side (r=0.640, p=0.034) and the cingulate bundle on the damaged side (r=0.544, p=0.083) in MAL. A correlation was observed for the damaged lateral cingulate bundle (r=0.544, p=0.083).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041941
