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NCT Number: NCT03530592

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

The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

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Key information

Conditions

Peripheral Nervous System Diseases Foot Drop Gait Disorders, Neurologic Mobility Limitation Mononeuropathies Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peroneal Neuropathies Signs and Symptoms

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location contact

Charlene E. Hafer-Macko, M.D.

PRINCIPAL_INVESTIGATOR

Kate C. Flores

CONTACT

About this study

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. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
  • Current participation in orthopedic or rehabilitation medical programs
  • Active deep venous thrombosis
  • Distal paretic leg skin lesions, infections, or soft tissue inflammation

Treatment and study plan

Seated Ankle Robot Training

Device

This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.

Primary outcomes

  1. 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

  2. Ankle inversion-eversion range of motion

    Time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

    degrees

  3. 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

  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 leg 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate C. Flores

CONTACT

[email protected]

(410) 637-3242

Sponsors and collaborators

Lead sponsor

Baltimore VA Medical Center

Fed

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
May 21, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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