Interactive Exoskeleton Robot for Walking - Knee Joint
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Functional Ambulation Category
Study Overview
Brief Summary
An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the gait pattern from the stroke patients and assist the walking and control the knee angle. The clinical trial will use repeated measurements to evaluate the effectiveness of the robotic knee system in gait rehabilitation post stroke.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ischemic or hemorrphagic stroke with drop foot problem.
- •Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination > 20)
- •Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category > 3, Berg Balance Scale > 40)
Exclusion Criteria
- •Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
- •Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
- •Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.
Arms & Interventions
Knee robot
This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton
Intervention: Knee robot (Device)
Outcomes
Primary Outcomes
Functional Ambulation Category
Time Frame: 3-month followup
Patients can be rated on the following categories: 0: Patient cannot walk, or needs help from 2 or more persons 1. Patients needs firm continuous support from 1 person who helps carrying weight and with balance 2. Patient needs continuous or intermittent support of one person to help with balance and coordination. 3. Patient requires verbal supervision or stand-by help from one person without physical contact 4. Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces 5. Patient can walk independently anywhere
6-minute Walk Test
Time Frame: 3-month followup
Walk as far a distance as possible over 6 minutes with their preferred speed; assistive devices can be used but kept consistent from test to test Individual should be able to ambulate without physical assistance.
Secondary Outcomes
- Kinematic and Kinetic Gait Motion Capture(3-month followup)
- Fugl-Meyer Assessment Lower Extremity(3-month followup)
- Timed 10-meter Walk Test(3-month followup)
- Modified Ashworth Scale(3-month followup)
- Berg Balance Scale(3-month followup)
Investigators
Raymond KY Tong
Professor
Chinese University of Hong Kong