UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019568 |
|---|---|
| Receipt number | R000022523 |
| Scientific Title | A study on usefulness of Walking Assist Device for gait disturbance |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2018/11/01 11:18:30 |
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Basic information
Public title
A study on usefulness of Walking Assist Device for gait disturbance
Acronym
Usefulness of Walking Assist Device
Scientific Title
A study on usefulness of Walking Assist Device for gait disturbance
Scientific Title:Acronym
Usefulness of Walking Assist Device
Region
| Japan |
Condition
Condition
Gait disturbance
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether use of Walking Assisit Device in rehabilitation results in improvement for patients with chronic gait disturbance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two times a week rehabilitation are performed for 5 weeks. We study 10 min walk test at the end of 5 weeks.
Key secondary outcomes
length of stride
Cadence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We investigate whether chronic gait disturbance improve by rehabilitation using Walking Assist Device.
Rehabilitation is performed 2 times a week for 5 weeks.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients performed rehabilitation at National Defense Medical College Hospital
Functional Ambulation Category >= 2
width between great trochanter: 290 - 372mm
length from hip to above patell 5cm: 306 - 363mm
obtained informed consent for research
Key exclusion criteria
severe complication
severe joint contracture
unhealed operation wound
epiepsy
dementia unable to obey instructions from therapists
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
tkobayas@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
Homepage URL
tkobayas@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Other
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
防衛医科大学校（埼玉）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | 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
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022523
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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