Skip to main content
OpenTrials
Completed

NCT Number: NCT02053233

Robot-assisted Training for Stroke Recovery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walkbot group

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.

Other names: Walkbot

Control group

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.

Other names: conventional treatment

Primary outcomes

  1. function ambulation category (FAC)

    Time frame: within 4 weeks after robot training

    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.

Secondary outcomes

  1. Berg balance scale (BBS)

    Time frame: within 4 weeks after robot training

    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.

  2. Korean modified Barthel index (K-MBI)

    Time frame: within 4 weeks after robot training

    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.

Other outcomes

  1. EuroQol-5 dimension (EQ-5D)

    Time frame: within 4 weeks after robot training

    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.

Sponsors and collaborators

Lead sponsor

Pusan National University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2014
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.