Effect of high-speed robot-assisted gait training for patients with stroke

UMIN ID: UMIN000054319

Registered date:07/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 2024/04/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The duration of the intervention will be at least 5 minutes x 2-3sets (10 minutes total), depending on the subject's fatigue, for a period of 8 days (7 days/week). The walking assistance robot will be the WellWalk WW-1000. The swing assist of the paralyzed leg on the Well Walk will be set to 6/6, which is the maximum, and the timing of the start of knee flexion during the swing phase, which is an assist function of the knee joint, the knee flexion angle, and the flexion speed will be adjusted to increase the stride length of the paralyzed leg and to practice walking at a faster speed than walking on a level ground or normal treadmill walking practice. Practice walking at higher speeds than for level walking or normal treadmill walking exercises. The treadmill speed during practice should be increased by 0.05 km/h if the patient can safely walk for more than 1 minute without catching the paralyzed leg; if the paralyzed leg catches even once in 1 minute, the treadmill speed should be decreased immediately by 0.05 km/h. The treadmill speed should be decreased by 3.5 km/h during the 8-day practice period. If the treadmill speed reaches 3.0 km/h during the 8-day practice period, the swing assist is decreased by 1 in the same manner as the treadmill speed.
Intervention 2 will be a normal treadmill walking exercise. The intervention time will be set at the same time as the gait practice using the walking aid robot, at least 5 minutes x 2-3 sets, depending on the subject's fatigue, and the duration will be 8 days (7 days/week). The treadmill speed during the practice will be gradually increased by 0.05 km/h if the subject can safely walk for more than 1 minute without catching the paralyzed leg. 0.05 km/h treadmill speed will be immediately decreased if the paralyzed leg is caught even once in 1 minute.

Outcome(s)

• Primary Outcome: Comfortable and maximum gait speed
• Secondary Outcome: Fugl-Meyer Assessment, Trunk Impairment Scale, Composite Spasticity Index, Isometric knee extensor strength, Berg Balance Scale, 6-Minute Distance, Timed Up and Go test, Functional Ambulation Categories

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Difficulty in understanding instructions due to aphasia or cognitive dysfunction

Related Information

• Primary Sponsor: Ukai Rehabilitaion Hospital
• Source(s) of Monetary Support: not applicable