UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006601 |
|---|---|
| Receipt number | R000007810 |
| Scientific Title | The effect of using the walking assistive device. |
| Date of disclosure of the study information | 2011/11/11 |
| Last modified on | 2013/04/19 11:48:53 |
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Basic information
Public title
The effect of using the walking assistive device.
Acronym
The effect of using the walking assistive device.
Scientific Title
The effect of using the walking assistive device.
Scientific Title:Acronym
The effect of using the walking assistive device.
Region
| Japan |
Condition
Condition
healhty young and older subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of walking assistive device on gait kinematics, muscle activation and exhaled gas in healthy young and older subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average value, maximal/minimum value, standard deviation and variance of gait speed, cadence, angle/moment/power of hip, knee and ankle joints, muscle activation of hip, thigh and calf muscles, and exhaled gas during gait with walking assistive device.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait with walking assistive device for approximately half an hour.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects who can understand the study and movement indicated.
Key exclusion criteria
Participants who have musculoskeletal disease of spine and lower extremity, have pain and deformity, have history of surgery.
Participants who have neurological disease and circulatory disease that inhibit the gait ability.
The students, graduates and faculty members belong to Department of Rehabilitation, School of Human Health Sciences, Faculty of Medicine, Kyoto University.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Ichihashi |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
Address
53 Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rui Tsukagoshi |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
Address
53 Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Homepage URL
tsukagoshi.r@fy7.ecs.kyoto-u.ac.jp
Sponsor or person
Institute
Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Honda R&D Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | 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
| 2011 | Year | 10 | Month | 24 | Day |
Last modified on
| 2013 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007810
