UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023069 |
|---|---|
| Receipt number | R000026591 |
| Scientific Title | Rehabilitation procedures construction for gait improvement of spinal cord injury patients |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2016/07/08 02:55:00 |
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Basic information
Public title
Rehabilitation procedures construction for gait improvement of spinal cord injury patients
Acronym
Rehabilitation procedures construction for gait improvement of spinal cord injury patients
Scientific Title
Rehabilitation procedures construction for gait improvement of spinal cord injury patients
Scientific Title:Acronym
Rehabilitation procedures construction for gait improvement of spinal cord injury patients
Region
| Japan |
Condition
Condition
spinal cord injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I improve gait posture of the spinal cord injury patient with the foot bottom sensory disturbance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking test
[Under intervention]
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Biofeedback by the electrical stimulation
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
| Not applicable |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Spinal cord injury(Frankle A or B).
2)After injury for not less than 1 year
3)65 years old or older
Key exclusion criteria
1)Patients with unstable cardiac status including
2)Patients unable to communicate with staff
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rina Hosoda |
Organization
Kochi Medical School hospital
Division name
Department of rehabilitation
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-805, Japan
TEL
(088)880-2490
jm-rina@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rina Hosoda |
Organization
Kochi Medical School hospital
Division name
Department of rehabilitation
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
(088)880-2490
Homepage URL
jm-rina@kochi-u.ac.jp
Sponsor or person
Institute
Department of rehabilitation, Kochi
Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | 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
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2016 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026591
