UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke.
Title of the study (Brief title)	Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke.
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and problem about Motor function and Activity of Daily Living for disabled persons using Hybrid Assistive Limb
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2 minutes walk test 10m walking test Functional Ambulation Categories
Key secondary outcomes	Step length Cadence Physiological Cost Index (PCI) Fugl-Meyer Assessment of Motor Recovery after Stroke Functional Balance Scale modified Ashworth Scale Knee-extension torque Functional Independence Measure (FIM) Functional Movement Scale EQ5D

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Participants will do trial fitting of HAL and then conduct 20 minutes ambulation exercises with HAL, 5 times a week for 5 weeks. Participants will take 40 min usual physical therapy.
Interventions/Control_2	Patients medical records who took 60 min usual physical therapy 5 time a week for 5 weeks will collect.
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient with first stroke Over 3 months after onset Less than 10% of the 2 minutes walking test improvement rate in continuous 3 weeks Able to sit in Wheel chair at least 30 minutes
Key exclusion criteria	Lesion of cerebellum or brain stem Subarachnoid hemorrhage Needs severe risk control in physical therapy Severe cognitive dysfunction Severe Higher Brain Dysfunction Severe sensory aphasia With severe contracture and deformities in lower limb Body weight above 80kg User of the active implantable medical devise
Target sample size	20

Research contact person
Name of lead principal investigator	Masafumi Mizukami
Organization	Ibaraki Prefectural University of Health Sciences
Division name	Graduated School of Health Sciences
Address	4669-2 Ami Ami-machi Ibaraki Japan
TEL	029-840-2162
Email	mizukami@ipu.ac.jp

Public contact
Name of contact person	Masafumi Mizukami
Organization	Ibaraki Prefectural University of Health Sciences
Division name	Graduated School of Health Sciences
Address	4669-2 Ami Ami-machi Ibaraki Japan
TEL	029-840-2162
Homepage URL
Email	mizukami@ipu.ac.jp

Sponsor
Institute	Ibaraki Prefectural University of Health Sciences
Institute
Department

Funding Source
Organization	Ibaraki Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	University of Tsukuba
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	茨城県立医療大学付属病院　 Ibaraki Prefectural University of Health Sciences Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 26 Day
Anticipated trial start date	2014 Year 01 Month 07 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry	2015 Year 10 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 01 Month 06 Day
Last modified on	2017 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014909