Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Northern Arizona University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Walking Speed
Study Overview
Brief Summary
The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).
Detailed Description
Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 5 and 35 years old, inclusive.
- •Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
- •Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
- •Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
- •The ability to read and understand English.
- •Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)
Exclusion Criteria
- •Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.
Arms & Interventions
Gait Training with Exoskeleton Assistance
Gait training with ankle exoskeleton assistance. All participants received high frequency gait training followed by a washout period then low frequency gait training.
Intervention: powered orthosis (Device)
Outcomes
Primary Outcomes
Change in Walking Speed
Time Frame: Measured at the pre (day 1) and post (day 4) gait training assessments
The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments
The Metabolic Energy Required to Walk
Time Frame: Measured at the pre (day 1) and post (day 4) gait training assessments
The change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training.
Secondary Outcomes
- Change in Muscle Activity Variance Ratio(Measured at the pre (day 1) and post (day 4) gait training assessments)
- Change in Cadence(Measured at the pre (day 1) and post (day 4) gait training assessments)
- Change in Stride Length(Measured at the pre (day 1) and post (day 4) gait training assessments)
Investigators
Zachary Lerner
Principal Investigator
Northern Arizona University