UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021453 |
|---|---|
| Receipt number | R000024737 |
| Scientific Title | Gait analysis of prothesis users using clinical motion analysis system |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2016/03/12 16:59:48 |
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Basic information
Public title
Gait analysis of prothesis users using clinical motion analysis system
Acronym
Gait analysis of prothesis users
Scientific Title
Gait analysis of prothesis users using clinical motion analysis system
Scientific Title:Acronym
Gait analysis of prothesis users
Region
| Japan |
Condition
Condition
Patients with amputation of extremity
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze gait motion of prothetic users and to compare with healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The angle of joint during gait
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with amputation
2.Time from amputation longer than 1 month
3.Ability to walk independently in daily life with or without assistance
4.Functional Independence Measure(FIM) is more than 100
Key exclusion criteria
1. Spontaneous pain in the amputation limbs
2. Arthritis in the unaffected leg
3. Contraindicate exercise therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meigen Liu |
Organization
Keio university faculty of medicine
Division name
Department of rehabilitation medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0353633833
meigenliukeio@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Liu |
Organization
Keio university faculty of medicine
Division name
Department of rehabilitation medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0353633833
Homepage URL
s03526fl@gmail.com
Sponsor or person
Institute
Keio university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Furukawa Medical and Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2016 | Year | 03 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | 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
Study design:
Observation(cross sectional study)
Recruitment:
05/01/2016-03/31/2018
Assessment:
Angle of joint, electromyography
Management information
Registered date
| 2016 | Year | 03 | Month | 12 | Day |
Last modified on
| 2016 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024737
