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Evaluating Wearable Robotic Assistance on Gait

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ClinicalTrials.gov Identifier: NCT04119063
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Zachary Lerner, 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).

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: powered orthosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility assessment of powered orthosis assistance and resistance during walking.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : January 18, 2023
Estimated Study Completion Date : January 18, 2023

Arm Intervention/treatment
Experimental: Exoskeleton Assistance
Walking with exoskeleton assistance to make walking easier.
Device: powered orthosis
Novel powered leg brace to provide assistance during walking.
Other Name: exoskeleton

Experimental: Exoskeleton Resistance
Walking with exoskeleton resistance for functional gait training.
Device: powered orthosis
Novel powered leg brace to provide assistance during walking.
Other Name: exoskeleton




Primary Outcome Measures :
  1. The metabolic energy required to walk [ Time Frame: Through study completion, an average of 8 weeks. ]
    Metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: J/kg/m

  2. Walking speed [ Time Frame: Through study completion, an average of 8 weeks. ]
    Walking speed measured over-ground or on a treadmill. Units: m/s

  3. Muscle activity [ Time Frame: Through study completion, an average of 8 weeks. ]
    Muscle activity during walking will be measured using electromyography electrodes. Units: mV

  4. Lower-extremity joint angles [ Time Frame: Through study completion, an average of 8 weeks. ]
    A motion capture system will be used to measure the posture of the body during walking. Units: Degrees

  5. Lower extremity joint moments [ Time Frame: Through study completion, an average of 8 weeks. ]
    A motion capture system and force plates will be used to measure the forces produced by the muscles of the body during walking. Units: Nm

  6. Change in energy required to walk [ Time Frame: Through study completion, an average of 8 weeks. ]
    We will compare the metabolic energy required to walk. Units: % change

  7. Change in 6 minute walk test [ Time Frame: Through study completion, an average of 8 weeks. ]
    We will compare the distance covered in 6 minutes of walking. Units: % change

  8. Change in muscle activity profile [ Time Frame: Through study completion, an average of 8 weeks. ]
    We will compare the muscle activity profile. Units: % change


Secondary Outcome Measures :
  1. Cadence [ Time Frame: Through study completion, an average of 8 weeks. ]
    Number of steps per minute will be measured. Units: steps/min



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Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 5 and 75 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119063


Contacts
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Contact: Zach Lerner, PhD 928-523-1787 Zachary.Lerner@nau.edu

Locations
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United States, Arizona
Northern Arizona University Recruiting
Flagstaff, Arizona, United States, 86011
Contact: Zach Lerner, PhD    928-523-1787    Zachary.Lerner@nau.edu   
Sponsors and Collaborators
Northern Arizona University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Responsible Party: Zachary Lerner, Principal Investigator, Northern Arizona University
ClinicalTrials.gov Identifier: NCT04119063    
Other Study ID Numbers: 986744
1R15HD099664-01 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases