UMIN-CTR Clinical Trial

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