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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016171
Receipt No. R000018766
Scientific Title Cutaneous Acupuncture Stimulations for Locomotive Pattern Modification in Gait for Volunteers and Patients with Chronic Hemiparesis
Date of disclosure of the study information 2015/01/09
Last modified on 2017/01/10

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Basic information
Public title Cutaneous Acupuncture Stimulations for Locomotive Pattern Modification in Gait for Volunteers and Patients with Chronic Hemiparesis
Acronym Cutaneous Acupuncture Stimulations for Locomotive Pattern Modification in Gait.
Scientific Title Cutaneous Acupuncture Stimulations for Locomotive Pattern Modification in Gait for Volunteers and Patients with Chronic Hemiparesis
Scientific Title:Acronym Cutaneous Acupuncture Stimulations for Locomotive Pattern Modification in Gait.
Region
Japan

Condition
Condition healthy volunteers and patients with chronic hemiparesis
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the influence of cutaneous stimulations for locomotive patterns in gait and changes of spasticity for patients with chronic hemiparesis. And in the long term its consequent influence to the daily living activity for patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.measurering H-reflex and H max/M max ratio before and after cutaneous acupuncture and sham acupuncture stimulations in the double blind cross over test.
2.legs muscles integral electromyographic activity during continuous walking before and after cutaneous acupuncture stimulations.
Key secondary outcomes 3.Physical assessments by MMT,Brunnstrom stage and Moified Ashworth scale.
4.Patients are monitored for the amount of daily physical activity time, steps, and exercise intensity for a month with cutaneous acupuncture and following further month with no stimulation. After each period, patients answered the stroke impact scale.

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
15 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healthy volunteers and patients with chronic hemiparesis (Brunnstrom stage III to VI (lower)
over 15 year old and no comunicatioin problem.
Key exclusion criteria patients who tendency to bleeding, communication by language is difficult, and very delicate skin which is easy to damaged.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyuki Matsumoto
Organization Showa University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address Fujigaoka 2-1-1 Aoba-ku Yokohama, Kanagawa 227-0043 Japan
TEL 81-45-974-2221
Email maam.miyuki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Matsumoto
Organization Showa University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address Fujigaoka 2-1-1 Aoba-ku Yokohama, Kanagawa 227-0043 Japan
TEL 81-45-974-2221
Homepage URL
Email maam.miyuki@gmail.com

Sponsor
Institute Department of Rehabilitation Medicine, Showa University School of Medicine
Institute
Department

Funding Source
Organization Public interest incorporated Foundation for Training and Licensure Examination
in Anma-Massage-Acupressure,Acupuncture and Moxibustion
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Miyuki Matsumoto, Masazumi Mizuma, Nobuyuki Kawate.: Cutaneous Acupuncture Stimulations for Locomotive Pattern Modification in Gait for Volunteers and Patients with Chronic Hemiparesis. 8th World congress of the International society of physical and rehabilitation medicine(ISPRM), 2015

Miyuki Matsumoto, Ari Yuasa, Masazumi Mizuma, Nobuyuki Kawate.: Effects of gentle cutaneous stimulation using contact and sham acupuncture on the H/M ratio in patients with chronic hemiparesis.Jounal of the Japan Society of Acupuncture and Moxibustion.65(s), p254, 2015

Miyuki Matsumoto, Masazumi Mizuma, Nobuyuki Kawate.: Effect of Cutaneous Acupuncture Stimulations on Gait Pattern in Patients with Chronic Hemiparesis. 9th World congress of the International society of physical and rehabilitation medicine(ISPRM), 2016
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 Main results already published
Date of protocol fixation
2014 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded
2015 Year 11 Month 30 Day

Other
Other related information no special information

Management information
Registered date
2015 Year 01 Month 09 Day
Last modified on
2017 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018766

Research Plan
Registered date File name
2016/07/13 研究実施計画書.pdf

Research case data specifications
Registered date File name
2016/07/13 入力データ.xlsx

Research case data
Registered date File name
2016/07/13 HM比統計用データ0612.xlsx


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