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

Not Applicable

Completed

• Conditions: Stroke; Gait, Hemiplegic
• Interventions: Device: Ankle Assist Robot

• Registration Number: NCT03767205
• Lead Sponsor: Samsung Medical Center

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

1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2018-12-17
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stroke patients	Ankle Assist Robot	All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).

Primary Outcome Measures

Name	Time	Method
Change on gait speed in different three conditions	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 Outcome Measures

Name	Time	Method
Change on gait function in different three conditions (kinetic)	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 kinetic using a force plate.
Change on metabolic energy expenditure in different three conditions	1 hour	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).
Change on gait function in different three conditions (muscle activation)	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 muscle activation using a surface EMG.
Change on gait function in different three conditions (kinematic)	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 kinematic using a motion analysis.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of