NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032180163

Registered date:27/02/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedcerebrovascular disease (with hemiplegia)
Date of first enrollment03/10/2018
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)gait training using curara(R) (25-35 min/day, 12 days in total) [day 1-day 6, day 8-day 13]

Outcome(s)

Primary Outcome1) 10m walking speed (comparison between day 0 and day 14) 2) 6-min walking distance (comparison between day 0 and day 14)
Secondary Outcome1) RehaGait(R) measures 2) Berg Balance Scale (BBS) [day 0, day 14] 3) Timed up and go test 4) Outcome measures reported by participants [day 14] Items not specified above by [] are evaluated three times, day 0, day 7, and day 14.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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
Exclude criteria1) 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.)

Related Information

Contact

Public contact
Name Kunihiro Yoshida
Address 3-1-1 Asahi, Matsumoto 390-8621, Nagano Pref., Japan Nagano Japan 390-8621
Telephone +81-263-37-3059
E-mail kyoshida@shinshu-u.ac.jp
Affiliation Shinshu University School of Medicine
Scientific contact
Name Kunihiro Yoshida
Address 3-1-1 Asahi, Matsumoto 390-8621, Nagano Pref., Japan Nagano Japan 390-8621
Telephone +81-263-37-3059
E-mail kyoshida@shinshu-u.ac.jp
Affiliation Shinshu University School of Medicine