Robot-assisted Training for Stroke Recovery

NCT02053233 | Completed

• 1 other identifier: PNUYH-03-2013-011
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; robot-assisted therapy; conventional therapy; motor function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Berg balance scale (BBS)

  within 4 weeks after robot training

• Korean modified Barthel index (K-MBI)

  within 4 weeks after robot training

Other Outcomes (1)

• EuroQol-5 dimension (EQ-5D)

  within 4 weeks after robot training

Study Arms (2)

Walkbot group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Walkbot

Walkbot group

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.

Also known as: conventional treatment

control group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yong-Il Shin, Ph.D.

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: February 3, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

KR (1)