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

Study Overview
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Brief Summary
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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)

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

Conditions
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Stroke, Gait, Hemiplegic

Intervention / Treatment
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* Device: Ankle Assist Robot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stroke patients<br>All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). | Device: Ankle Assist Robot<br>* overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on gait speed in different three conditions | 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. | 20minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on gait function in different three conditions (kinematic) | All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinematic using a motion analysis. | 20minutes | 
| Change on gait function in different three conditions (kinetic) | All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinetic using a force plate. | 20minutes | 
| Change on gait function in different three conditions (muscle activation) | All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of muscle activation using a surface EMG. | 20minutes | 
| Change on metabolic energy expenditure in different three conditions | All participants perform treadmill walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy). | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait function, Metabolic energy expenditure, ankle assist robot