Robot-assisted Training for Stroke Recovery

Pusan National University

Status: Completed

Conditions: Stroke

Treatments: Device: Walkbot group; Device: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02053233

PNUYH-03-2013-011

Details and patient eligibility

About

The robot assisted therapy is one of the new developed technologies for recovery after stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery after stroke.

Full description

This study designed an assessor-blinded, randomized, controlled clinical study. The participations followed the study protocol and were randomly divided into the control group and Walkbot group. The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. Whereas the Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.

Enrollment: 26 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects (age>19) with stroke 4 weeks after the onset but within 12 months were included.

Exclusion criteria

• Participated in the clinical studies, or received the rehabilitation therapy or therapy associated with the rehabilitation for the purpose of motor function improvement within thirty days before the start of this study.
• Cognitive disabilities or serious psychiatric illness.
• Difficulty in walking due to orthopedic problems.
• Ejection fraction less than 30% due to severe heart disease or with a diagnosis of unstable angina.
• Weight more than 135 kg or height less than 150 cm.
• Pregnancy subjects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups, including a placebo group

Walkbot group

Experimental group

Description:

The Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks.

Treatment:

Device: Walkbot group

control group

Placebo Comparator group

Description:

The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.

Treatment:

Device: Control group