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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767205
• Other study ID #: 2018-06-128
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke

Intervention

Device:
• Ankle Assist Robot
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).

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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