NCT03767205CompletedNot Applicable
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 enrollmentStarted: December 17, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change on gait speed in different three conditions
Study 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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
stroke patients
Experimental
All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).
Intervention: Ankle Assist Robot (Device)
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)
Investigators
Study Sites (1)
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