UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial to prove the improvement efficacy of the walking program using the wearable assistive robot HAL for the patients with hemiparesis due to stroke.
Acronym	HIT-2016
Scientific Title	Randomized controlled trial to prove the improvement efficacy of the walking program using the wearable assistive robot HAL for the patients with hemiparesis due to stroke.
Scientific Title:Acronym	HIT-2016
Region	Japan

Condition
Condition	The patient with hemiparesis due to cerebrovascular disease.
Classification by specialty	Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate of the improvement efficacy and safety of the walking program, using the wearable assistive robot HAL (HAL-TS01) for the patients with hemiparesis due to cerebrovascular disorders, compare with usual rehabilitation program.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	10 m Maximum Walking Speed (10m MWS)
Key secondary outcomes	1. Averaged step length and Cadence at 10m MWS 2. Asymmetry ratio at 10m MWS 3. 6-Minute walk Distance(6MD) 4. Functional Ambulation Categories (FAC) 5. Berg Balance Scale (BBS) 6. Fugl-Meyer Assessment (FMA)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Walking program wearing HAL-TS01
Interventions/Control_2	Walking program without HAL-TS01
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.1st inclusion (1)The patient who the agreement document is possible by himself. (2)The patient who is less than five months after the onset by stroke. (3)The patient who the wearing of HAL is possible. (4)The patient who is available hospitalization during study period. 2. 2nd inclusion (1)The patient who 10m MWS is 30-60 m/min at the last measurement of the pre-observation period. (2)The patient who the improvement ratio is under 10%, 5%, and 5% sequentially for 3 weeks in the pre-observation period. The averaged value is the mean of 10m MWS of the week previous two and the week concerned. The improvement ratio is calculated from the 3 averaged values.
Key exclusion criteria	1.1st Exclusion (1)The patient with subarachnoid hemorrhage. (2)The patient who can walk outdoor independently. (3)The patient who investigator/subinvestigotor recognized the following symptom. 1)The patient who have akinesia, rigidity, and ataxia with high grade. 2)The patient whom rehabilitation cannot be performed to in the training room. 3)The patient who cannot understand the command and have communication. 4)The patient who has muscle spasm, deformity and contracture on the lower extremity with high grade. (4)The patient who caused waling disorder due to the spinal disease, the peripheral nerve disease, muscle disease, and injury except stroke, and has sever sensory disturbance, and severe lower limbs ischemic disease. (5)The patient who has liver damage, renal damage, cardiovascular disease, and respiratory disease with high grade. (6)The patient with the malignant tumor that does not cure radically. (7)The patient who cannot make the electrode adherent to the body surface by skin disease. (8)The patient who needs hospitalization treatment by the bone fracture, contusion, injury, and its complication in 3months before the pre-observation period. (9)The patient who the bleeding tendency and osteoporosis with the problem on the walking practice. (10)The patient who was included to other clinical trials in 3 months before the 1st inclusion, or has the plan to participate with others. (11)The patient who did walking practice using other robot equipment. (12)The patient who MD judged it no good to participate to the clinical trial. 2.2nd Exclusion (1)The patient who cannot do operation of HAL by CVC mode on the hip joint or knee joint at the end of pre-observation period. (2)The patient who MD judged it no good to participate to the clinical trial.
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Tsurushima
Organization	University of Tsukuba Hospital
Division name	Dept. of Neurosurgery
Zip code	305-8576
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
TEL	029-853-3220
Email	hideo-tsurushima@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Hashimoto
Organization	University of Tsukuba, Tsukuba Clinical Research & Development Organization
Division name	Clinical Research Service Center
Zip code	305-8576
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
TEL	029-853-3064
Homepage URL
Email	koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ibaraki Chiken Network IRB
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
Tel	029-853-3749
Email	ibarakichiken@un.tsukuba.ac.jp

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

筑波大学附属病院（茨城県） University of Tsukuba Hospital (Ibaraki)、茨城県立医療医大付属病院（茨城県） Ibaraki Prefectural University of Health Sciences Hospital (Ibaraki)、福岡大学病院（福岡県） Fukuoka University Hospital (Fukuoka)、福岡リハビリテーション病院（福岡県） Fukuoka Rehabilitation Hospital (Fukuoka)、志村大宮病院（茨城県） Shimuraomiya Hospital (Ibaraki)、国立病院機構　新潟病院（新潟県）National Nigata Hospital, National Hospital Organization (Nigata), 兵庫県立リハビリテーション中央病院 （兵庫県）Hyogo Rehabilitation Center、長崎北病院（長崎県）Nagasaki Kita Hospital, 大分リハビリテーション病院（大分県）Oita Rehabilitation Hospital, 千葉県千葉リハビリテーションセンター（千葉県）Chiba Rehabilitation Center, 原宿リハビリテーション病院（東京都）Harajuku Rehabilitation Hospital, 白十字病院（福岡県）Hakujyuji Hospital, 一宮西病院（愛知県）Ichinomiyanishi Hospital, 尾西記念病院（愛知県）Bisaikinen Hospital, 上林記念病院（愛知県）kamibayashikinen Hospital, 札幌秀友会病院（北海道）Sapporo syuyukai Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 14 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	2016 Year 09 Month 30 Day
Date of IRB	2016 Year 05 Month 27 Day
Anticipated trial start date	2016 Year 11 Month 14 Day
Last follow-up date	2020 Year 12 Month 09 Day
Date of closure to data entry	2020 Year 12 Month 23 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2020 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545