Interactive Exoskeleton Robot for Walking - Ankle Joint
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Functional Ambulation Category
Study Overview
Brief Summary
A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.
Detailed Description
In this clinical trial, participated stroke patients will be divided into two groups: Robotic group and Sham group. Stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. Robotic group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. A series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
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 > 21)
- •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 follow-up.
Outcomes
Primary Outcomes
Functional Ambulation Category
Time Frame: 3-month follow-up
Assesses postural stability during various walking tasks
6-minute Walk Test
Time Frame: 3-month follow-up
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance
Secondary Outcomes
- Berg Balance Scale(3-month follow-up)
- Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity)(3-month follow-up)
- Kinematic and Kinetic Gait Motion Capture(3-month follow-up)
- Timed 10 Meter Walk Test(3-month follow-up)
- Modified Ashworth Scale(3-month follow-up)
- Subjective Feedback Questionnaire(3-month follow-up)
Investigators
Raymond KY Tong
Professor
Chinese University of Hong Kong