NCT03709329

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

Completed NA Last updated 28 September 2020

What this trial tests

NA trial testing Robot Assisted Gait Therapy in Chronic Post-stroke Hemiplegic Patients in 40 participants. Completed in 4 November 2019.

Timeline

25 July 2018

Primary endpoint
4 November 2019

4 November 2019

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	25 July 2018
Primary completion	4 November 2019
Estimated completion	4 November 2019
Sites	1 location across South Korea

Drugs / interventions tested

• Robot Assisted Gait Therapy
• Conventional Gait Therapy

Conditions studied

• Chronic Post-stroke Hemiplegic Patients — all drugs for Chronic Post-stroke Hemiplegic Patients →

Sponsor

Yonsei University

Who can join

18 and older, any sex, with Chronic Post-stroke Hemiplegic Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Electromechanical-assisted training for walking after stroke.
   Mehrholz J, Thomas S, Kugler J, Pohl M, et al · · 2020 · cited 146× · PMID 33091160 · DOI 10.1002/14651858.cd006185.pub5