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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021907
Receipt No. R000025262
Scientific Title Studies on rehabilitation for patients with chronic spinal cord injury using robot suits called Hybrid Assistive Limb (HAL)
Date of disclosure of the study information 2016/04/15
Last modified on 2019/04/16

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Basic information
Public title Studies on rehabilitation for patients with chronic spinal cord injury using robot suits called Hybrid Assistive Limb (HAL)
Acronym Studies on rehabilitation using robot suits called Hybrid Assistive Limb (HAL)
Scientific Title Studies on rehabilitation for patients with chronic spinal cord injury using robot suits called Hybrid Assistive Limb (HAL)
Scientific Title:Acronym Studies on rehabilitation using robot suits called Hybrid Assistive Limb (HAL)
Region
Japan

Condition
Condition Patients with chronic spinal cord injury and postoperative patients with spinal cord diseases.
Classification by specialty
Orthopedics Radiology Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness of neuro-rehabilitation using HAL on patients with chronic spinal cord injury and postoperative patients with spinal cord diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1)Motor function evaluation: score the motor function using ASIA score,
in addition measure the skeletal muscle mass index
2)Walking ability,sense of equilibrium : using Barthal index,2 minutes walk test , 10m walking test, Time up and go test , and Berg Balance Scale.
3)Sensory function evaluation : score the motor function using ASIA score
4)Resting-state functional MRI (Rs-fMRI): Analyze the brain connectivity in patients using fMRI, and to analyze the correlation of brain connectivity and motor function recovery.
Key secondary outcomes Questionnaire survey: SF-36, VAS index, PainDETECT, degree of satisfaction, Clinical Global Impression.

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 NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 neuro-rehabilitation using HAL
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Satisfy the following conditions
1.age:20-75 years old
2.The patients with chronic spinal cord injury(over 6 month after injury) or the postoperative patients with spinal cord disease(over 6 month after operation),who reached the plateau of the functional recovery.
3.The patients who have more than 1 score in manual test of lower limbs and can't walk by themselves.
4.The patients were informed about their disease and received the explanation about using HAL and outcome evaluation. In addition, the patients agree to perform the neuro-rehabilitation using HAL.
Key exclusion criteria Poor general condition due to SCI
Difficult to take fMRI
No informed consent
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name Masaya
Middle name
Last name Nakamura
Organization Keio University School of Medicine
Division name Orthopaedic surgery
Zip code 1608582
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3809
Email masa@keio.jp

Public contact
1st name of contact person
1st name Masaya
Middle name
Last name Nakamura
Organization Keio University School of Medicine
Division name Orthopaedic surgery
Zip code 1608582
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3809
Homepage URL
Email masa@a8.keio.jp

Sponsor
Institute Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo JAPAN
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
The Uehara Memorial foundation
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 IRB committee of Keio University School of Medicine
Address 35 Shinanomachi Shinjuku
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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 慶応義塾大学医学部/慶応義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 15 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 20
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 Completed
Date of protocol fixation
2016 Year 02 Month 19 Day
Date of IRB
2016 Year 04 Month 13 Day
Anticipated trial start date
2016 Year 04 Month 30 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
2016 Year 04 Month 14 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025262

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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