Effects of End-effector Type Robot Assisted Gait Therapy on Gait Pattern and Energy Consumption in Chronic Post-stroke Hemiplegic Patients

NCT03709329 | Completed

• 1 other identifier: 1-2018-0032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Restoration of gait independence in stroke patients is one of the most important goals of rehabilitation therapy, and gait rehabilitation is one of the most important treatments in the treatment of stroke because it is a major factor affecting rehabilitation after stroke. In the rehabilitation of patients with post - stroke walking disorders, previous physical therapy was mainly manual therapy using therapist 's physical effort and walking training with walking aids. In recent years, however, emphasis has been placed on therapies based on motor learning concepts, which allow the patient to intensively train the exercise as closely as possible to the ultimate goal. The robot used for walking rehabilitation includes exoskeleton walking robot such as Lokomat® (Hocoma AG, Switzerland), Walkbot-G® (P \& S Mechanics, Korea), MorningWalk® (Curexo, Korea) According to the Systematic Review, which compares two types of robot-assisted gait treatment divided into end-effector type, which is not an exoskeletal type such as System® (Rehatech, Switzerland) It has been reported that the percentage of patients who were able to walk independently when treated with a robot was higher than that of an exoskeleton-type robot. In this regard, in terms of acquisition of independent gait, studies on the therapeutic effect of the exoskeleton-type robot and the end-effector-type robot before and after the gait therapy were continuously performed, but 80% of the patients obtained independent gait, Despite the fact that many of these patients have abnormal walking, research has not yet been conducted. In previous studies, there was a statistically significant improvement in parameters of Gait speed, Cadence, and step length when compared with spatiotemporal parameters in training using exoskeleton robots for stroke patients. In another study, Gait speed and Cadence did not show a statistically significant improvement, and the effect on Gait speed and Cadence is still unknown. However, unlike exoskeletal robots, end-effector robotic gait training has been reported to improve Gait speed in most studies compared to conventional gait training. In addition, Cadence, Temporal symmetry ratio, Single, an improved side stride length, an improvement in the symmetry index of stance phase, and an improvement in Gait endurance. In this way, the end effector type robot walking training is more likely to improve walking quality than the exoskeleton type robot. The end-effector type robot, which is different from the exoskeleton type, reproduces the gait using the ankle joint to induce the movement of the knee joint and the hip joint. Therefore, it is possible to control the ankle joint, which is essential for improving the gait pattern. It is considered that the end effector type robot which can control the ankle joint is more likely to induce the improvement of the gait pattern than the existing exoskeleton type robot because it shows limitations in reproducing the ankle rocker motion.

Conditions

Chronic Post-stroke Hemiplegic Patients

Keywords

End-effector; Robot Assisted Gait Therapy; Gait Pattern; Energy Consumption; Chronic stroke; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Difference of Self selected gait velocity between before and after Robot Assisted Gait Therapy

  The change of gait speed that the patient feels most comfortable with according to the flow of the three time points (before and immediately after treatment and after 6 weeks of treatment)

  before and immediately after treatment and after 6 weeks of treatment

Secondary Outcomes (11)

• Difference between two interventional groups according to the time course

  before and immediately after treatment and after 6 weeks of treatment

• Dynamic EMG

  before and immediately after treatment and after 6 weeks of treatment

• Foot pressure

  before and immediately after treatment and after 6 weeks of treatment

• Fugl-Meyer Assessment(FMA) for Lower extremities

  before and immediately after treatment and after 6 weeks of treatment

• 10m walking test

  before and immediately after treatment and after 6 weeks of treatment

Study Arms (2)

Robot Assisted Gait Therapy

EXPERIMENTAL

The robot-assisted gait treatment will receive 18 treatments per patient for 1 week, 3 times a week, and 6 weeks for 30 minutes a day.

Device: Robot Assisted Gait Therapy

Conventional Gait Therapy

ACTIVE COMPARATOR

The conventional gait therapy group receives a total of 18 classical gait training sessions once a day for 30 minutes and three times a week for 6 weeks. Classical gait training consisted of exercise training based on neurophysiological theories such as Bobath, restraint of rigid and cooperative movements by therapists, exercise training in sitting or standing posture, Gait training and balance training, weight training of the paralyzed lower limb.

Device: Conventional Gait Therapy

Interventions

Robot Assisted Gait Therapy DEVICE

The robot-assisted gait treatment will receive 18 treatments per patient for 1 week, 3 times a week, and 6 weeks for 30 minutes a day.

Robot Assisted Gait Therapy

Conventional Gait Therapy DEVICE

The conventional gait therapy group receives a total of 18 classical gait training sessions once a day for 30 minutes and three times a week for 6 weeks. Classical gait training consisted of exercise training based on neurophysiological theories such as Bobath, restraint of rigid and cooperative movements by therapists, exercise training in sitting or standing posture, Gait training and balance training, weight training of the paralyzed lower limb.

Conventional Gait Therapy

Eligibility Criteria

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

You may qualify if:

• Stroke patient visited Shinchon Severance Hospital Rehabilitation Department
• Adults over 19 years
• Ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging or computed tomography
• Patients who have had a stroke for more than 3 months
• Those who have hemiplegia after a stroke
• If the walking pattern is abnormal and the walking speed is less than 0.8m / sec
• Those who have a score of K-MMSE score of 24 or higher in the Korean version
• A person who can walk independently with 3 or more points in the Functional Ambulation Category (FAC) classified as 0 \~ 5 according to the degree of need for assistance in walking
• The patients who understand the research and have voluntary participation

You may not qualify if:

• Those who have difficulty walking before stroke
• Modified Ashworth scale of the lower extremity muscle is 3 or more
• Patients with ataxia
• Severe lower extremity joints, osteoporosis, and untreated fractures.
• Patients who weigh more than 135kg
• Damage of the skin in contact with the machine during robot walking
• Patients who underwent orthopedic or neurosurgical surgery within 6 months of the start of the study
• uncontrolled hypertension or orthostatic hypotension
• Patients who are likely to spread pathogenic microorganisms due to contact
• Not cutting
• Cardiovascular disease, venous thrombosis or heart failure, respiratory disease
• Malignant neoplasm
• Other basic diseases that can not tolerate robot assisted walking
• If the tester is judged as not suitable for this study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Outcome assessors were blinded to types of treatment the patients received until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded Randomized controlled study design is divided into two groups: robot-assisted walking group and conventional walking group. The random assignment is performed by Stratified Permuted Block Randomization to match Sex and Age between the two groups, and the subject is assigned using a randomly generated table before the start of the study so that the evaluator can not know what kind of treatment the subject is receiving. Both groups undergo unassisted overground walking condition before and after treatment and after 6 weeks of treatment. Plain gait condition at the time of evaluation: When walking, several 8-meter-long plazas are walked several times to induce a natural walk, and three natural gait cycles are selected.

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 17, 2018
• Study Start: July 25, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)