Evaluating Wearable Robotic Assistance on Gait

Early Phase 1CompletedNCT04119063

Northern Arizona University6 enrolled

Overview

The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

powered orthosisDEVICE

Novel powered leg brace to provide assistance during walking.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Northern Arizona University

Flagstaff, Arizona, United States

Outcomes

Primary Outcomes

The Metabolic Energy Required to Walk

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.