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

JRCT ID: jRCTs032180163

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cerebrovascular disease (with hemiplegia)
• Date of first enrollment: 03/10/2018
• Target sample size: 40
• Study type: Interventional
• 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 Outcome

1) 10m walking speed (comparison between day 0 and day 14)
2) 6-min walking distance (comparison between day 0 and day 14)

Secondary Outcome

1) 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 maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.)

Related Information

• Primary Sponsor: Yoshida Kunihiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)
• Secondary ID(s): UMIN000034237