UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016171 |
|---|---|
| Receipt number | 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 09:48:59 |
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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
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
maam.miyuki@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Showa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
