Evaluating Wearable Robotic Assistance on Gait

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: powered orthosis

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86011
      • Northern Arizona University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: powered orthosis; Novel powered leg brace to provide assistance during walking.; Other Names: exoskeleton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured at the pre (day 1) and post (day 4) gait training assessments
Change in Walking Speed	The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments	Measured at the pre (day 1) and post (day 4) gait training assessments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stride Length	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.	Measured at the pre (day 1) and post (day 4) gait training assessments
Change in Cadence	The change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments.	Measured at the pre (day 1) and post (day 4) gait training assessments
Change in Muscle Activity Variance Ratio	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.	Measured at the pre (day 1) and post (day 4) gait training assessments

Collaborators and Investigators

• Sponsor: Northern Arizona University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• Orekhov G, Fang Y, Cuddeback CF, Lerner ZF. Usability and performance validation of an ultra-lightweight and versatile untethered robotic ankle exoskeleton. J Neuroeng Rehabil. 2021 Nov 10;18(1):163. doi: 10.1186/s12984-021-00954-9.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2019
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 986744; 1R15HD099664-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No