UMIN-CTR Clinical Trial

Public title

Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 1 cerebrovascular disease

Acronym

Rehabilitation trial using curara(R) for patients with cerebrovascular diseases

Scientific Title

Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 1 cerebrovascular disease

Scientific Title:Acronym

Rehabilitation trial using curara(R) for patients with cerebrovascular diseases

Region

Japan

Condition

cerebrovascular disease (CVD)

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to verify the efficacy and safety of the short-term, inpatient rehabilitation (gait training) using curara(R) for CVD patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

10m walking speed (comparison between day 0 and day 14) [day 0, day 7, day 14]
[] indicates day of evaluation

Key secondary outcomes

1) 6-min walking distance (comparison between day 0 and day 14)
2) RehaGait(R) measures
3) Berg Balance Scale (BBS) [day 0, day 14]
4) Timed up and go test
5) Outcome measures reported by participants [day 14]
6) Safety sheet (interview to participants) [at least 1 day during 3 days just prior to day 0 and day 0-day 14]

Items not specified above by [] are evaluated three times, day 0, day 7, and day 14.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

gait training using curara(R) (25-35 min/day, 12 days in total) [day 1-day 6, day 8-day 13]

Interventions/Control_2

standardized gait training without curara(R) (25-35 min/day, 12 days in total) [day 1-day 6, day 8-day 13]

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with cerebrovascular disease (CVD) presenting with hemiplegia
2) Age: 20 years <= at entry
3) Duration after onset ranges from 14 to 90 days
4) Able to walk 10 m (even with walking aids such as cane or walker)
5) Able to keep admission in Kakeyu-Misayama Rehabilitation Center, Kakeyu Hospital during the study
6) Berg balance Scale: 26<=
7) Written informed consent for the study

Key exclusion criteria

1) Possible causes for gait disturbance other than CVD
2) Not fulfil the body-size criteria for curara(R) model 4
3) Researchers judge the participants inappropriate for the study (for example, severe dementia or psychiatric symptoms, severe spasticity or joint contracture of paralyzed leg, etc.)

Target sample size

40

Name of lead principal investigator

1st name	Kunihiro
Middle name
Last name	Yoshida

Organization

Shinshu University School of Medicine

Division name

Department of Brain Disease Research

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto 390-8621, Japan

TEL

0263-37-3059

Email

kyoshida@shinshu-u.ac.jp

Name of contact person

1st name	Kunihiro
Middle name
Last name	Yoshida

Organization

Shinshu University School of Medicine

Division name

Department of Brain Disease Research

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto 390-8621, Japan

TEL

0263-37-3059

Homepage URL

Email

kyoshida@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and
Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shinshu University

Address

3-1-1 Asahi, Matsumoto 390-8621, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-u.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

JA厚生連　鹿教湯三才山リハビリテーションセンター鹿教湯病院（長野県）

Date of disclosure of the study information

2018

Year

10

Month

02

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000038939

Publication of results

Unpublished

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000038939

Number of participants that the trial has enrolled

40

Results

We analyzed data from 35 patients in total (Group A: 17; Group B: 18). The averaged improvement rate of 10 m walking time was 0.21 for Group A, and 0.14 for Group B, respectively (p = 0.099). The averaged improvement rate of 6 min walking distance was 0.17 for Group A, and 0.19 for Group B, respectively (p = 0.677). Group A tended to show better results in several gait parameters taken by RehaGait than Group B, but the difference was not statistically significant.

Results date posted

2022

Year

03

Month

31

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Forty adult patients (male: 28; female: 12) with cerebrovascular diseases (cerebral infarction: 20; cerebral hemorrhage: 20) who showed hemiplegia were enrolled. The mean age of the patients was 64.5 years old. The patients' profiles were as follows: Functional Independent Measure (FIM) was 74.3 (mean), 12 grading scale (Ueda style single paralysis function tests) was 10.7 (mean), and the mean 10 m waling time was 12.5 sec. These patients were randomly classified into two study groups, Group A with curara and Group B without curara.

Participant flow

Out of 40 patients, 4 patients were dropped out from the study. 3 were from Group A and 1 was from Group B, respectively. One patient who dropped out from Group A developed skin problem by wearing curara and the other two intended to retract their consent to the study. One patient from Group B developed cerebral hemorrhage again during the study. Thirty six patients completed the study without any particular problems.

Adverse events

One patient who dropped out from Group A developed skin problem in the outside of her knee joints, thus, the physician in charge wanted to cease the study. We judged to stop the study in one patient in Group B because she developed cerebral hemorrhage again during the study.

Outcome measures

improvement rate of 10 m walking time
improvement rate of 6 min walking distance

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

10

Month

01

Day

Date of IRB

2018

Year

10

Month

02

Day

Anticipated trial start date

2018

Year

10

Month

09

Day

Last follow-up date

2020

Year

06

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

09

Month

22

Day

Last modified on

2022

Year

03

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038939