Effects of gait exercise assist robot

JRCT ID: jRCTs052180228

Registered date:30/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic stroke
• Date of first enrollment: 11/09/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Gait exercise assist robot training: Training performed twenty session(40min/day, 5day/week for 4weeks). Treadmill training: Training using only treadmill in gait exercise assist robot (not robot and monitor off) performed twenty session (40min/day, 5day/week for 4weeks).

Outcome(s)

Primary Outcome

1. Gait pattern
2. Physical cost index

Secondary Outcome

1. 10m gait velocity
2. 6 minute walk distance
3. Timed up and go test
4. Global rating of change scale
5. MOS 8 Item Short Form Health Survey

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. >6 months duration after stroke
2. Hemiparesis of unilateral, supratentorial, ischemic, or
hemorrhage stroke
3. Independent in ground ambulation with or without the
use of a unilateral assistive device (standard cane,
four-pronged cane) and with or without the use of a an
ankle foot orthoses
4. Independent in treadmill gait training
5. approval for study participation

Exclude criteria

1. Cannot obey instructions of a healer (scores < 23 on the Mini Mental Status examination, etc)
2. Significant cardiorespiratory/metabolic disease, or orthopedic injury or other neurological
3. Excessive spasticity (defined as Ashworth scale of
greater than 3 at any lower limb joint)
4. Size limitations for the harness/counterweight system or robotic orthosis
5. No botulinum toxin therapy in the lower limbs < 4 months
prior to enrollment

Related Information

• Primary Sponsor: Domen Kazuhisa
• Source(s) of Monetary Support: TOYOTA Motor Corporation
• Secondary ID(s): 000028042