UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of gait rehabilitation with Hybrid Assistive Limb in Stroke patients
Title of the study (Brief title)	Effects of gait rehabilitation with HAL in Stroke patients
Region	Japan

Condition
Condition	Post-stroke patients
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of gait rehabilitation with HAL in stroke patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Functional Ambulation Category Outcome measures are evaluate to prior to training, after training, and follow-up period.
Key secondary outcomes	Fugl-Meyer Assessment of the lower extremity, muscle strength, gait speed, gait capacity, TUG, SF-8, adverse event.

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	Gait rehabilitation with HAL 3 times a week with a total of 12 or 18 HAL program sessions. One session is 20 minutes.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects with hemiparesis due to unilateral cerebral infarction or intra cerebral hemorrhage. 2) Within 6 months after stroke onset. 3) Subject with a score of from 0 to 3 on the Functional Ambulation Category.
Key exclusion criteria	1) Subjects could not put on the electrode surface of skin due to skin disease. 2) Subjects with size limitations for the robot suit HAL. 3) Subjects could not conventional gait treatment due to serious cardiopulmonary dysfunction.
Target sample size	20

Research contact person
Name of lead principal investigator	Hisako Yanagi
Organization	University of Tukuba
Division name	Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan.
TEL	029-853-3496
Email	hyanagi@md.tsukuba.ac.jp

Public contact
Name of contact person	Hiroki Watanabe
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.
TEL	029-853-1131
Homepage URL
Email	s1430398@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
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)

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 08 Month 03 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 01 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	2017 Year 08 Month 03 Day
Last modified on	2017 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032648