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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023469
Receipt No. 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

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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
Email 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
Email tkobayas@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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