UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014336
Receipt No. R000016680
Scientific Title The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.
Date of disclosure of the study information 2014/07/01
Last modified on 2016/09/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.
Acronym The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.
Scientific Title The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.
Scientific Title:Acronym The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.
Region
Japan

Condition
Condition The central moter dysfunction associated with stroke, cerebrospinal injury, cerebrospinal tumor and neuromusclar disease
Classification by specialty
Neurology Orthopedics Neurosurgery
Emergency medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the safety and feasibility of clinical trials to evaluate the promotion of improvement in central motor dysfuction by performing the treatment of functional recovery using HAL in the acute phase.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Adverse event
2. Failure of HAL and ancillary equipment
3. Feasibility of study protocol
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 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 The treatment of functional recovery using HAL for single joint or HAL for lower limb, about 2 times for a week.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients can consent by a document. If the handwriting is difficult due to the primary disease, it is assumed to obtain a document consent from ghost-writing user.
2. Patients 16 years of age or older. The consent of the legal representative's is needed for the patients of minors 16-20 years of age.
3. Patients who are hospitalized in the general ward, ICU or HCU.
4. Patients can wear HAL, weighing 40-100 kg, height is 150-190 cm.
5. Patients who can be hospitalized continuously along the test schedule.
Key exclusion criteria 1. It is difficult to perform the volantary movement of the limbs in accordance with the instructions due to the disturbance of consciousness or dementia.
2. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system.
3. Patients has a complication, which can disturb the treatment using HAL.
4. The biological edectrode for HAL can not be affixed to patient's skin due to the skin disease.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Matsumura
Organization Faculty of Medicine, University of Tsukuba
Division name Division of Clinical Medicine, Department of Neurosurgery
Zip code
Address 1-1-1 Tennodai Tsukuba, Ibaraki Japan
TEL 029-853-3220
Email a-matsumur@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiki Marushima
Organization Faculty of Medicine, University of Tsukuba
Division name Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine
Zip code
Address 1-1-1 Tennodai Tsukuba, Ibaraki Japan
TEL 029-853-3220
Homepage URL
Email aiki.marushima@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
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
Address
Tel
Email

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
2014 Year 07 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
2014 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 14 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
2014 Year 06 Month 21 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016680

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.