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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025529
Receipt No. R000029098
Scientific Title The effects of electrical muscle stinulation during walking on kinematics of knee and physical function.
Date of disclosure of the study information 2017/01/05
Last modified on 2018/07/08

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Basic information
Public title The effects of electrical muscle stinulation during walking on kinematics of knee and physical function.
Acronym The effectiveness of electrical muscle stimulation on knee muscles during walking.
Scientific Title The effects of electrical muscle stinulation during walking on kinematics of knee and physical function.
Scientific Title:Acronym The effectiveness of electrical muscle stimulation on knee muscles during walking.
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of Hybrid gait training system with electrical stimulation on physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.muscle strength of knee extensor
2.10 meters gait speed
3.knee joint pain
4.chair stand test in 5 seconds
Key secondary outcomes 1.range of motion of knee joint
2.blood tests
3.X-ray inspection
4.Gait analysis
5.KOOS(Knee injury and Osteoarthritis Outcome Score)
6.JKOM (Japanese Knee Osteoarthritis Measure)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The subject is instructed to walk at self-selected speed with electrical stimulation device twice or 3 times a week. One excercise takes 30 minites and performs at intervals of more than 36 hours. We set three groups. This group is control group without electrical stimulation in walking.
Interventions/Control_2 The subject is instructed to walk at self-selected speed with electrical stimulation device twice or 3 times a week. One excercise takes 30 minites and performs at intervals of more than 36 hours. We set three groups.This group is instructed to walk under electrical stimulation for quadriceps and hamstrings at every stance phases in walking.
Interventions/Control_3 The subject is instructed to walk at self-selected speed with electrical stimulation device twice or 3 times a week. One excercise takes 30 minites and performs at intervals of more than 36 hours. We set three groups.This group is instructed to walk under electrical stimulation for quadriceps at every stance phases and hamstrings at every swing phases in walking.
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1.primary osteoarthritis of the knee(KL garade 1-4)
2.over 40 years old
3.walking alone
Key exclusion criteria 1.unable to use the device of electrical stimulation
2.unable to walk alone
3.other disease of orthopaedic
4.post opelation effects of walking
5.Rheumatoid arthrosis
6.uncontrol hyper tention
7.skin trouble or musculoskeltal disease
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Shiba
Organization Department of Medicine, Kurume University School of Medicine
Division name Division of Orthopedics
Zip code
Address 67, Asahi-machi, Kurume City, Fukuoka Prefecture
TEL 0942-31-7568
Email nshiba@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiro Matsuse
Organization Department of Medicine, Kurume University School of Medicine
Division name Division of Orthopedics
Zip code
Address 67, Asahi-machi, Kurume City, Fukuoka Prefecture
TEL 0942-31-7568
Homepage URL
Email matsuse_hiroh@kurume-u.ac.jp

Sponsor
Institute Division of Orthopedics, Department of Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 久留米大学医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 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
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
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 06 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 01 Month 04 Day
Last modified on
2018 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029098

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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