Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03556709
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Charlene Elaine Hafer-Macko, M.D., Baltimore VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Foot Drop Peripheral Nervous System Diseases Gait Disorders, Neurologic Mobility Limitation Device: Treadmill Ankle Robot Training Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treadmill Ankle Robot Training Device: Treadmill Ankle Robot Training
This intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.




Primary Outcome Measures :
  1. Gait velocity during self-selected overground walking [ Time Frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training ]
    cm/sec

  2. Peak dorsiflexion angle during swing phase of gait [ Time Frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training ]
    degrees; extent of ankle dorsiflexion to enable foot clearance

  3. Ankle dorsiflexion-plantarflexion range of motion [ Time Frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training ]
    degrees

  4. Postural sway areas during quiet standing [ Time Frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training ]
    cm^2; extent of postural deviations to assess static postural control

  5. Ratio of asymmetric loading in quiet standing [ Time Frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training ]
    ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly

  6. Push-off forces during gait initiation [ Time Frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training ]
    Newtons; magnitude of forward ground reaction forces.



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:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03556709


Contacts
Layout table for location contacts
Contact: Kate C. Flores (410) 637-3242 kate.flores@va.gov

Sponsors and Collaborators
Baltimore VA Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Charlene E. Hafer-Macko, M.D. Baltimore VA Medical Center

Layout table for additonal information
Responsible Party: Charlene Elaine Hafer-Macko, M.D., Associate Professor of Neurology, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT03556709     History of Changes
Other Study ID Numbers: HP-00080575
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Diseases
Mobility Limitation
Peripheral Nervous System Diseases
Peroneal Neuropathies
Gait Disorders, Neurologic
Signs and Symptoms
Neuromuscular Diseases
Mononeuropathies
Neurologic Manifestations