UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients
Title of the study (Brief title)	Effects of Rehabilitation using the 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	To compare the efficacy of gait training using a single-leg version of the Hybrid Assistive Limb (HAL) on the paretic side with conventional gait training in individuals with stroke.
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 prior to training, after 12 sessions (4 weeks), and at 8 and 12 weeks after intervention initiation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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
Interventions/Control_1	HAL group perform gait training using the HAL 3 times a week with a total of 12 HAL training sessions (4 weeks).
Interventions/Control_2	Conventional group perform conventional gait training (CGT) 3 times a week with a total of 12 CGT training sessions (4 weeks).
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	Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke Time since stroke onset of within six months
Key exclusion criteria	1) Patients did not consent in this study. 2) Patients not ambulating prior to stroke. 3) Patients with a score of 4 or 5 on the Functional Ambulation Category. 4) Patients with severe disturbance of consciousness (II or III on the Japan Coma Scale). 5) Patients with severe cardiac disease (New York Heart Association Classification of III or IV) . 6) Patients with size limitations for the robotic orthosis. 7) Persons on whom it was impossible to paste an electrode because of skin disease. 8) Persons who had an implanted pacemaker.
Target sample size	40

Research contact person
Name of lead principal investigator	Hisako Yanagi
Organization	University of Tsukuba
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	watanabe.hiroki.gb@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	筑波記念病院(茨城県)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 17 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 02 Month 06 Day
Anticipated trial start date	2013 Year 02 Month 06 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 17 Day
Last modified on	2017 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025743