UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Acronym	Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Scientific Title	Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Scientific Title:Acronym	Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Region	Japan

Condition
Condition	stroke, spinal cord injury, knee/hip joint injury
Classification by specialty	Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to investigate the safety and efficacy of HAL in rehabilitation medicine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of myopotential signals of each lower limb muscle
Key secondary outcomes	1)video image 2)range of motion of the joints in the lower extremities 3)muscle strength of the lower extremities 4)cardiopulmonary function (heart rate, blood pressure, rating of perceived exertion(Borg Scale)) 5)satisfaction with the assistance in mobility provided by HAL

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	to walk 10m wearing HAL at the first day and the last day of rehabilitation
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects who are diagnosed as stroke, spinal cord injury, or knee/hip joint injury Subjects must satisfy the following conditions for inclusion: 1.who have difficulty walking and cannot walk independently 2.who are fully informed and understand about this study, and then provide the written voluntary consent to participation
Key exclusion criteria	The following patients will be excluded: 1.who are under 20 years old 2.who are determined to have difficulty understanding due to dementia ,higher brain dysfunction and the other reason 3.who have poorly controlled hypertension, heart failure, osteoporosis, and the other disease 4.who are in life-threatening medical condition, and are forbidden exercise by a doctor 5.who are determined as unsuitable subjects by investigators for various other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Etsuo Chosa
Organization	University of Miyazaki Hospital
Division name	Rehabilitation unit and Orthopaedic Surgery
Zip code
Address	5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL	0985-85-0986
Email	seikei@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Etsuo Chosa
Organization	University of Miyazaki Hospital
Division name	Rehabilitation unit and Orthopaedic Surgery
Zip code
Address	5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL	0985-85-0986
Homepage URL
Email	seikei@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 13 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	Completed
Date of protocol fixation	2013 Year 11 Month 14 Day
Date of IRB	2019 Year 11 Month 22 Day
Anticipated trial start date	2013 Year 11 Month 14 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry	2020 Year 03 Month 30 Day
Date trial data considered complete	2020 Year 03 Month 30 Day
Date analysis concluded	2020 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 10 Day
Last modified on	2020 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029379