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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036811
Receipt No. 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 2019/05/21

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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
50 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 3 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
Email 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
Email ot-dep@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2020 Year 05 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
2019 Year 05 Month 21 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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