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

Baltimore VA Medical Center

Status: Not yet enrolling

Conditions: Gait Disorders, Neurologic; Peripheral Nervous System Diseases; Mobility Limitation; Foot Drop

Treatments: Device: Seated Ankle Robot Training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03530592

HP-68734

Details and patient eligibility

About

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.

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No 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. Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
2. Current participation in orthopedic or rehabilitation medical programs
3. Active deep venous thrombosis
4. Distal paretic leg skin lesions, infections, or soft tissue inflammation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Seated Ankle Robot Training

Experimental group

Treatment:

Device: Seated Ankle Robot Training