UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016357 |
|---|---|
| Receipt number | R000018974 |
| Scientific Title | Evaluation on the lower limb exoskeleton of supporting standing and sitting motion for spinal disease patients |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2015/01/28 01:28:14 |
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Basic information
Public title
Evaluation on the lower limb exoskeleton of supporting standing and sitting motion for spinal disease patients
Acronym
Exoskeleton with passive assistive limb for supporting postural transition
Scientific Title
Evaluation on the lower limb exoskeleton of supporting standing and sitting motion for spinal disease patients
Scientific Title:Acronym
Exoskeleton with passive assistive limb for supporting postural transition
Region
| Japan |
Condition
Condition
Spinal disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performance evaluation of the lower limb exoskeleton of supporting standing and sitting motion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of body movement such as limbs, torso, shoulder and head, with the lower limb exoskeleton in standing and sitting motion
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Supporting standing and sitting motion by using the lower limb exoskeleton
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients with lower limb paralysis who has the difficulty to keep standing in their own limb
- Paraplegic patients, spinal disease patients who are capable of holding upper body
- No mental health problem, and sufficient to perform the experiment
Key exclusion criteria
- Any patients with spasticity and solid contraction interfere with keeping standing posture
- Patient with dizziness or blood pressure drop problems during the practice of standing
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yamazaki |
Organization
University of Tsukuba
Division name
Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3219
masashiy@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
University of Tsukuba
Division name
Center for Cybernics Resaerch
Zip code
Address
1-1-1 Tennodai, Tsukuba, Japan
TEL
029-853-5761
Homepage URL
kenji@ieee.org
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Center for Cybernics Research, University of Tsukuba
Organization
Division
Category of Funding Organization
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 15 | 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 | 01 | Month | 28 | Day |
Last modified on
| 2015 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018974
