Evaluating Wearable Robotic Assistance on Gait

Early Phase 1

Completed

Conditions: Cerebral Palsy

Interventions: Device: powered orthosis

Registration Number: NCT04119063

Lead Sponsor: Northern Arizona University

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gait Training with Exoskeleton Assistance	powered orthosis	Gait training with ankle exoskeleton assistance. All participants received high frequency gait training followed by a washout period then low frequency gait training.

Primary Outcome Measures

Name	Time	Method
Change in Walking Speed	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	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 Outcome Measures

Name	Time	Method
Change in Muscle Activity Variance Ratio	Measured at the pre (day 1) and post (day 4) gait training assessments	The change in the muscle activity variance ratio of the soleus during walking will be measured using electromyography electrodes. Units: % change between post vs pre assessments.
Change in Cadence	Measured at the pre (day 1) and post (day 4) gait training assessments	The change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments.
Change in Stride Length	Measured at the pre (day 1) and post (day 4) gait training assessments	The change in the stride length will be measured by dividing the number of steps by distance traveled. Units: % change between post vs pre assessments.