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

NCT ID: NCT03530592

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2028-12-31

Brief Summary

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.

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seated Ankle Robot Training

Group Type: EXPERIMENTAL

Seated Ankle Robot Training

Intervention Type: DEVICE

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

Interventions

Seated Ankle Robot Training

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

Intervention Type: DEVICE

Eligibility 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. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baltimore VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Charlene Elaine Hafer-Macko

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charlene E. Hafer-Macko, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center

Locations

Baltimore VA Medical Center

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Kate C. Flores

Role: CONTACT

kate.flores@va.gov

(410) 637-3242

Facility Contacts

Kate C. Flores

Role: primary

Other Identifiers

HP-68734

Identifier Type: -

Identifier Source: org_study_id