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

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

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Kate C. Flores; (410) 637-3242; kate.flores@va.gov

Sponsors and Collaborators

Baltimore VA Medical Center

Investigators

• Principal Investigator: Charlene E. Hafer-Macko, M.D.; Baltimore VA Medical Center

More Information

• Responsible Party: Charlene Elaine Hafer-Macko, M.D., Associate Professor of Neurology, Baltimore VA Medical Center
• ClinicalTrials.gov Identifier: NCT03556709
• Other Study ID Numbers: HP-00080575
• First Posted: June 14, 2018
• Last Update Posted: June 14, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Nervous System Diseases; Gait Disorders, Neurologic; Peripheral Nervous System Diseases; Peroneal Neuropathies; Mobility Limitation; Neurologic Manifestations; Neuromuscular Diseases; Mononeuropathies