The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients

Samsung Medical Center1 site in 1 country45 target enrollmentDecember 17, 2018

ConditionsStroke Gait, Hemiplegic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Samsung Medical Center
Enrollment: 45
Locations: 1
Primary Endpoint: Change on gait speed in different three conditions
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing

gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)

Registry

clinicaltrials.gov

Start Date

December 17, 2018

End Date

December 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Stroke patients with hemiplegia over 19 years old
•Ischemic or hemorrhagic stroke patients over 3 months of onset
•Functional Ambulation Category Scale with 3 or more scales

Exclusion Criteria

•Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures
•Stroke patients with walking difficulty due to serious cognitive problems
•Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot
•Stroke patients at risk of falling when walking with severe dizziness
•Modified ashworth scale (MAS) Stroke patients over 3
•Pregnant woman
•People with mental illness and psychiatric medication

Outcomes

Primary Outcomes

Change on gait speed in different three conditions

Time Frame: 20minutes

All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.

Secondary Outcomes

Change on gait function in different three conditions (kinetic)(20minutes)
Change on metabolic energy expenditure in different three conditions(1 hour)
Change on gait function in different three conditions (muscle activation)(20minutes)
Change on gait function in different three conditions (kinematic)(20minutes)