UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042025 |
|---|---|
| Receipt number | R000047863 |
| Scientific Title | Study on the efficacy of walking assist in gait training |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2023/12/01 23:34:43 |
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Basic information
Public title
Study on the efficacy of walking assist in gait training
Acronym
Study on the efficacy of walking assist in gait training
Scientific Title
Study on the efficacy of walking assist in gait training
Scientific Title:Acronym
Study on the efficacy of walking assist in gait training
Region
| Japan |
Condition
Condition
Patients with orthopedic, neurological or neurosurgical conditions who are able to practice walking
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy after using Honda walking assist device as walking training during rehabilitation for incomplete spinal cord injury in our hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (injury, dermatopathy, etc.)
Key secondary outcomes
Efficacy
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
Walking exercise using Honda walking assist device during rehabilitation (up to 20 mins/day, 3-5days/week) for 2 to 4 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are hospitalized in our hospital or visited our hospital.
Patients who can practice walking.
Key exclusion criteria
Patients under the age of 20.
Patients whose height is less than 140 cm.
Patients with marked cognitive decline and higher brain dysfunction.
Patients using a pacemaker.
Patients who have difficulty wearing Honda walking assist device.
Patients who are judged inappropriate by medical doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Mutsuzaki |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Inashiki-gun, Ibaraki
TEL
029-888-4000
mutsuzaki@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Mutsuzaki |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
mutsuzaki@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
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
Ethics Committee of the Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Inashiki-gun, Ibaraki
Tel
029-888-4000
ishiika@ipu.ac.jp
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
| 2020 | Year | 10 | Month | 06 | 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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047863
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
