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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030080
Receipt No. R000034343
Scientific Title Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Date of disclosure of the study information 2017/11/22
Last modified on 2018/12/18

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Basic information
Public title Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Acronym Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Scientific Title Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Scientific Title:Acronym Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to verify the effects of concurrent peripheral nerve stimulation (PNS) therapy on the forearm of the paralyzed side of the body, upper limb function, and improved movement in daily living of the stroke patients with upper limb paralysis underdoing repetitive transcranial magnetic stimulation (r-TMS) therapy and 2-week intensive occupation therapy (OT).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Wolf motor function test
Key secondary outcomes Fugl-Meyer Assessment
Motor Activity Log

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Apply one hour per day of PNS therapy to the forearm of the paralyzed side of the body during OT to stroke patients with upper limb paralysis who are undergoing r-TMS therapy and 2-week intensive OT.
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

Not applicable
Gender Male and Female
Key inclusion criteria Aged 20 years or older at the time consent was obtained.
Ability to voluntarily extend at least three fingers, including the thumb.
Ability to raise the arm on the affected side to the level of the nipple or higher.
Six months or more have passed since the onset of stroke.
PNS therapy has been prescribed by the patient's physician.
Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria Severe aphasia, agnosia, apraxia, or other severe higher brain dysfunction that interferes with the procedures of the study.
Cutaneous anesthesia.
Having an inflammatory disease with arthritic inflammation, such as rheumatoid arthritis.
Previous participation in this study.
Previous history of receiving concurrent PNS therapy with r-TMS therapy.
Patients who have otherwise been determined to be ineligible as a subject by the principal investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Mutai
Organization Shinshu University
Division name Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2405
Email hitmutai@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Mutai
Organization Shinshu University
Division name Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2405
Homepage URL
Email hitmutai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 鹿教湯病院(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 22 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
2017 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034343

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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