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Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

Primary Purpose

Foot Drop, Peripheral Nervous System Diseases, Gait Disorders, Neurologic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill Ankle Robot Training
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Drop

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women, aged 18 to 88 years
  2. Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
  3. Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device[s] is permitted)

Exclusion Criteria:

  1. Cardiac history of (a) unstable angina; (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); and/or (c) hemodynamically significant valvular dysfunction
  2. Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments)
  3. Medical history of (a) recent hospitalization (less than 3 months) for severe medical disease; (b) symptomatic peripheral arterial occlusive disease; (c) orthopedic or chronic pain conditions that significantly alter gait function; (d) pulmonary or renal failure; and/or (e) active cancer
  4. Current participation in orthopedic or rehabilitation medical programs
  5. Active deep venous thrombosis
  6. Distal paretic leg skin lesions, infections, or soft tissue inflammation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treadmill Ankle Robot Training

    Arm Description

    Outcomes

    Primary Outcome Measures

    Gait velocity during self-selected overground walking
    cm/sec
    Peak dorsiflexion angle during swing phase of gait
    degrees; extent of ankle dorsiflexion to enable foot clearance
    Ankle dorsiflexion-plantarflexion range of motion
    degrees
    Postural sway areas during quiet standing
    cm^2; extent of postural deviations to assess static postural control
    Ratio of asymmetric loading in quiet standing
    ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
    Push-off forces during gait initiation
    Newtons; magnitude of forward ground reaction forces.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2018
    Last Updated
    June 4, 2018
    Sponsor
    Baltimore VA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03556709
    Brief Title
    Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
    Official Title
    Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2028 (Anticipated)
    Study Completion Date
    December 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baltimore VA Medical Center

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this research study is to test the utility of an ankle robot, when used during treadmill walking, in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.
    Detailed Description
    Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling. This study will focus on PNS injuries that cause foot drop. Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable. The investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop, when used during treadmill walking. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Foot Drop, Peripheral Nervous System Diseases, Gait Disorders, Neurologic, Mobility Limitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treadmill Ankle Robot Training
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Treadmill Ankle Robot Training
    Intervention Description
    This intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.
    Primary Outcome Measure Information:
    Title
    Gait velocity during self-selected overground walking
    Description
    cm/sec
    Time Frame
    Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
    Title
    Peak dorsiflexion angle during swing phase of gait
    Description
    degrees; extent of ankle dorsiflexion to enable foot clearance
    Time Frame
    Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
    Title
    Ankle dorsiflexion-plantarflexion range of motion
    Description
    degrees
    Time Frame
    Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
    Title
    Postural sway areas during quiet standing
    Description
    cm^2; extent of postural deviations to assess static postural control
    Time Frame
    Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
    Title
    Ratio of asymmetric loading in quiet standing
    Description
    ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
    Time Frame
    Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
    Title
    Push-off forces during gait initiation
    Description
    Newtons; magnitude of forward ground reaction forces.
    Time Frame
    Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    88 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women, aged 18 to 88 years Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device[s] is permitted) Exclusion Criteria: Cardiac history of (a) unstable angina; (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); and/or (c) hemodynamically significant valvular dysfunction Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments) Medical history of (a) recent hospitalization (less than 3 months) for severe medical disease; (b) symptomatic peripheral arterial occlusive disease; (c) orthopedic or chronic pain conditions that significantly alter gait function; (d) pulmonary or renal failure; and/or (e) active cancer Current participation in orthopedic or rehabilitation medical programs Active deep venous thrombosis Distal paretic leg skin lesions, infections, or soft tissue inflammation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kate C. Flores
    Phone
    (410) 637-3242
    Email
    kate.flores@va.gov
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charlene E. Hafer-Macko, M.D.
    Organizational Affiliation
    Baltimore VA Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

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