UMIN-CTR Clinical Trial

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

The patient with hemiparesis due to cerebrovascular disease.

Classification by specialty

Neurosurgery

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

University of Tsukuba Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ibaraki Chiken Network IRB

Address

2-1-1 Amakubo, Tsukuba, Ibaraki

Tel

029-853-3749

Email

ibarakichiken@un.tsukuba.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2016

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

11

Day

Last modified on

2020

Year

12

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545