Robot-assisted Training for Stroke Recovery

Clinical Trial of Robot-assisted Training for Motor and Gait Recovery in Patients With Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Walkbot group; Device: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of, 626-770
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.; Other Names: Walkbot
PLACEBO_COMPARATOR: 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.	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.; Other Names: conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
function ambulation category (FAC)	Function ambulation category was used for evaluating gait function. The outcome variable were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.	within 4 weeks after robot training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg balance scale (BBS)	Berg balance scale (BBS) were used for evaluating functional performance level after training. The outcome variables were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.	within 4 weeks after robot training
Korean modified Barthel index (K-MBI)	Korean modified Barthel index (K-MBI) were used for evaluating functional performance level after training. The outcome variables were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.	within 4 weeks after robot training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol-5 dimension (EQ-5D)	EuroQol-5 dimension (EQ-5D) was used for evaluating the effect of robot training to quality of life. The outcome variable was measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.	within 4 weeks after robot training

Collaborators and Investigators

• Sponsor: Pusan National University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (ESTIMATE): February 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2014
• Last Update Submitted That Met QC Criteria: January 31, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: stroke; robot-assisted therapy; motor function; conventional therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PNUYH-03-2013-011