Evaluating Wearable Robotic Assistance on Gait

NCT04119063 | Completed Early Phase 1 Results FDA Device

• 2 other identifiers: 9867441R15HD099664-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Stride Length

  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 Muscle Activity Variance Ratio

  Measured at the pre (day 1) and post (day 4) gait training assessments

Study Arms (1)

Gait Training with Exoskeleton Assistance

EXPERIMENTAL

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

Interventions

powered orthosis DEVICE

Novel powered leg brace to provide assistance during walking.

Also known as: exoskeleton

Gait Training with Exoskeleton Assistance

Eligibility Criteria

• Age: 5 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

Related Publications (1)

• 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.

  PMID: 34758857 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

Small sample size due to participant recruitment challenges in our location and resulting from Covid 19.

Results Point of Contact

• Title: Zach Lerner, Associate Professor
• Organization: Northern Arizona University

Zachary.Lerner@nau.edu

928-523-1787

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility assessment of powered orthosis assistance and resistance during walking. All participants received high frequency gait training followed by a washout period then low frequency gait training.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: September 8, 2019
• Primary Completion: November 20, 2022
• Study Completion: November 20, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2024-01

Locations

US (1)