Skip to main content
OpenTrials
Completed

NCT Number: NCT04119063

Evaluating Wearable Robotic Assistance on Gait

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northern Arizona University

Flagstaff, Arizona, 86011, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Powered orthosis

Device

Novel powered leg brace to provide assistance during walking.

Other names: exoskeleton

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Change in Stride Length

    Time frame: 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.

  2. Change in Cadence

    Time frame: 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.

  3. Change in Muscle Activity Variance Ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northern Arizona University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2019
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.