UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058879 |
|---|---|
| Receipt number | R000067338 |
| Scientific Title | Effect of Using a Lumbar-Type Wearable Robot (HAL) on Low Back Pain Reduction in Rehabilitation Staff |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/24 16:43:07 |
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Basic information
Public title
Effect of Lumbar-Type HAL on Reducing Low Back Pain in Rehabilitation Staff
Acronym
A study to see whether using the HAL robot can reduce low back pain in rehabilitation staff
Scientific Title
Effect of Using a Lumbar-Type Wearable Robot (HAL) on Low Back Pain Reduction in Rehabilitation Staff
Scientific Title:Acronym
Effect of Using a Lumbar-Type Wearable Robot (HAL) on Low Back Pain Reduction in Rehabilitation Staff
Region
| Japan |
Condition
Condition
Occupational low back pain (in rehabilitation staff)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether wearing the lumbar-type HAL during clinical duties reduces low back pain in rehabilitation staff
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in NRS score for low back pain before and after wearing HAL
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants wear the lumbar-type HAL during clinical duties, and low back pain and fatigue are evaluated
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
| 27 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Rehabilitation staff with low back pain and/or fatigue
Key exclusion criteria
none
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | MIZUNASHI |
| Middle name | |
| Last name | FUMIYA |
Organization
Ama City Hospital
Division name
Department of Rehabilitation
Zip code
490-1111
Address
1 Azeta, Jimokuji, Ama-shi, Aichi 490-1111, Japan
TEL
090-7859-5674
f05511033@gmail.com
Public contact
Name of contact person
| 1st name | MIZUNASHI |
| Middle name | |
| Last name | FUMIYA |
Organization
Ama City Hospital
Division name
Department of Rehabilitation
Zip code
490-1111
Address
1 Azeta, Jimokuji, Ama-shi, Aichi 490-1111, Japan
TEL
052-444-0050
Homepage URL
f05511033@gmail.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Ama city hospital
Address
1 Azeta, Jimokuji, Ama-shi, Aichi 490-1111, Japan
Tel
090-7859-5674
f05511033@gmail.com
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
| 2025 | Year | 08 | Month | 25 | 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
39
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
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067338
