We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Wearable Robotic Assistance on Gait

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119063
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : March 23, 2023
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Zachary Lerner, Northern Arizona University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : December 18, 2024
Estimated Study Completion Date : December 18, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Zach Lerner, PhD 928-523-1787 Zachary.Lerner@nau.edu

Locations
Layout table for location information
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)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases