UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of Hybrid Assistive Limb (HAL) in the patients with spinal cord injury.
Title of the study (Brief title)	The effects of HAL in the patients with spinal cord injury.
Region	Japan

Condition
Condition	patients with spinal cord injury
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of HAL on gait ability in patients with spinal cord injury.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	10-m walk test , 6 minutes walk test
Key secondary outcomes	TUG, gait analysis, accelerometer, BBS, Gait Judge System, surface EMG, fNIRS, ADL (FIM), Stroke impact Scale, questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	gait exercise with 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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) patients with spinal cord injury 2) stable medical condition, and duration from the onset of SCI is over 1 month 3) ability to walk indoor 4) age is over 20 years 5) patients who agree to participate in this study
Key exclusion criteria	1) patients who could not resord the EMG signal 2) severe higher cortical dysfunction, dementia, loss of consciousness 3) pacemaker implantation, or severe cardiopulmonary disease 4) severe restriction of ROM
Target sample size	20

Research contact person
Name of lead principal investigator	Shuji Matsumoto
Organization	Kagoshima University
Division name	Dept. of Rehabilitation
Address	3930-7 Takachiho, Makizono-cho, Kirishima City
TEL	0995-78-2538
Email	shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Shuji Matsumoto
Organization	Kagoshima University
Division name	Dept. of Rehabilitation
Address	3930-7 Takachiho, Makizono-cho, Kirishima City
TEL	0995-78-2538
Homepage URL
Email	shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 05 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 02 Month 02 Day
Anticipated trial start date	2016 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 04 Day
Last modified on	2016 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027052