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

Primary Purpose

Stroke, Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ankle Assist Robot
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring gait function, Metabolic energy expenditure, ankle assist robot

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stroke patients

Arm Description

All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
December 2, 2018
Last Updated
December 5, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03767205
Brief Title
The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Official Title
The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait, Hemiplegic
Keywords
gait function, Metabolic energy expenditure, ankle assist robot

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stroke patients
Arm Type
Experimental
Arm Description
All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).
Intervention Type
Device
Intervention Name(s)
Ankle Assist Robot
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change on gait speed in different three conditions
Description
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.
Time Frame
20minutes
Secondary Outcome Measure Information:
Title
Change on gait function in different three conditions (kinematic)
Description
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.
Time Frame
20minutes
Title
Change on gait function in different three conditions (kinetic)
Description
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.
Time Frame
20minutes
Title
Change on gait function in different three conditions (muscle activation)
Description
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.
Time Frame
20minutes
Title
Change on metabolic energy expenditure in different three conditions
Description
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).
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YunHee Kim, Kim
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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