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Clinical Trials/NCT04119063
NCT04119063
Completed
Early Phase 1

Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment

Northern Arizona University1 site in 1 country6 target enrollmentSeptember 8, 2019
ConditionsCerebral Palsy

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Northern Arizona University
Enrollment
6
Locations
1
Primary Endpoint
Change in Walking Speed
Status
Completed
Last Updated
2 years ago

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).

Registry
clinicaltrials.gov
Start Date
September 8, 2019
End Date
November 20, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zachary Lerner

Principal Investigator

Northern Arizona University

Eligibility Criteria

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.

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)

Study Sites (1)

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