Robot-assisted Training for Stroke Recovery

NCT ID: NCT02053233

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Walkbot group

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.

Group Type: EXPERIMENTAL

Walkbot group

Intervention Type: DEVICE

The physiotherapist typed patient's information then Walkbot would adjust itself to this data and the exoskeleton legs lengthen or shorten to the patient. The computer screen would provide information about speed, duration, cadence and distance. The monitor in front of the patient can offer image and feedback during the therapy process for patients.

The whole Walkbot training process was observed by one physiotherapist and should be always ready to adjust the unloading, duration, speed and guidance force of Walkbot according to patients' different situation such as muscle spasticity, gait quality, labor-consuming and observe the changes of patients' state.

control 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. 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.

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DEVICE

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.

Interventions

Walkbot group

The physiotherapist typed patient's information then Walkbot would adjust itself to this data and the exoskeleton legs lengthen or shorten to the patient. The computer screen would provide information about speed, duration, cadence and distance. The monitor in front of the patient can offer image and feedback during the therapy process for patients.

The whole Walkbot training process was observed by one physiotherapist and should be always ready to adjust the unloading, duration, speed and guidance force of Walkbot according to patients' different situation such as muscle spasticity, gait quality, labor-consuming and observe the changes of patients' state.

Intervention Type: DEVICE

Control 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. 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.

Intervention Type: DEVICE

Other Intervention Names

Walkbot; conventional treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong-Il Shin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

PNUYH-03-2013-011

Identifier Type: -

Identifier Source: org_study_id