UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031025 |
|---|---|
| Receipt number | R000035428 |
| Scientific Title | Locomotor functional improvement with Cybernic system for locomotive syndrome |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/10/30 23:38:39 |
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Basic information
Public title
Locomotor functional improvement with Cybernic system for locomotive syndrome
Acronym
Locomotor improvement with Cybernic system
Scientific Title
Locomotor functional improvement with Cybernic system for locomotive syndrome
Scientific Title:Acronym
Locomotor improvement with Cybernic system
Region
| Japan |
Condition
Condition
Locomotive syndrome
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove safety and feasibility of HAL lumbar type and HAL mono-articulr type for locomotive syndrome
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse events related to locomotor training using HAL for locomotive syndrome
Key secondary outcomes
Alteration of vital signs pre- and post-locomotor training with HAL (vital signs will be measured using Vital sensor)
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
HAL lumbar type or HAL mono-articular
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who agree to participate in the current trial and from whom informed consent was obtained orally and in writing.
2. Patients who is possible to install HAL lumbar type and/or HAL mono-articular type
3. Patient who correspond to locomotive syndrome (with the criterion for locomotive syndrome made by Japanese Orthopedic Association)
Key exclusion criteria
1. Patient who cannot install HAL because of skin disease
2. Patient who is not applicable to locomotor training due to severe comorbidity
3. Patient who cannot agree to participate in the current study due to consciousness disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yamazaki |
Organization
University of Tsukuba
Division name
Department of Orthopedic Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba-City, Ibaraki, Japan
TEL
029-853-3219
masashiy@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Koda |
Organization
University of Tsukuba
Division name
Department of Orthopedic Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba-City, Ibaraki, Japan
TEL
029-853-3219
Homepage URL
masaokod@gmail.com
Sponsor or person
Institute
ImPACT project by Cabinet Office, Goverment of Japan
Institute
Department
Personal name
Funding Source
Organization
ImPACT project by Cabinet Office, Goverment of Japan
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
筑波大学病院（茨城県）、社会福祉法人 永寿福祉会 老人保健施設 永寿ケアセンター（大阪府）、医療法人社団 幹人会 介護老人保健施設菜の花（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035428
