UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023469 |
|---|---|
| Receipt number | R000022507 |
| Scientific Title | Usefulness of wearable robot "Bionic Leg" in rehabilitation |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2019/08/06 09:21:23 |
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Basic information
Public title
Usefulness of wearable robot "Bionic Leg" in rehabilitation
Acronym
Usefulness of"Bionic Leg"
Scientific Title
Usefulness of wearable robot "Bionic Leg" in rehabilitation
Scientific Title:Acronym
Usefulness of"Bionic Leg"
Region
| Japan |
Condition
Condition
disuse syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether "Bionic leg" is useful or not in order to prevent deconditioning or recover from disuse syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of improvement of patients who can stand up from bed owing to usage of "Bionic Leg"
Key secondary outcomes
Improvement of FIM score until discharge from the hospital
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with difficulty of standing up are performed rehabilitation using Vionic Leg.
Interventions/Control_2
Patients with difficulty of standing up are performed ordinary rehabilitation.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients performed rehabilitation at National Defense Medical College Hospital
Weight 50 - 135 kg
possible of sitting
unable to stand up
informed consent is obtained
Key exclusion criteria
impossible of sitting
dementia unable to understand instructions of therapists
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
359-8513
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
tkobayas@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
359-8513
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
Homepage URL
tkobayas@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
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
National Defense Medical College
Address
3-2, Namiki, Tokorozawa, Saitama
Tel
0429951511
tkobayas@ndmc.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
防衛医科大学校
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 03 | 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
0
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
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 03 | Day |
Last modified on
| 2019 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022507
