UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025529 |
|---|---|
| Receipt number | 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 | 2023/03/19 14:44:24 |
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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
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
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Division of Orthopedics, Department of Medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
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
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029098
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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