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

Not Applicable

Not yet recruiting

• Conditions: Gait Disorders, Neurologic; Foot Drop; Peripheral Nervous System Diseases; Mobility Limitation
• Interventions: Device: Seated Ankle Robot Training

• Registration Number: NCT03530592
• Lead Sponsor: Baltimore VA Medical Center

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.

Study Timeline

• Study First Submitted: 2018-04-10
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21
• Study Start: 2018-06-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seated Ankle Robot Training	Seated Ankle Robot Training	-

Primary Outcome Measures

Name	Time	Method
Ankle dorsiflexion-plantarflexion range of motion	Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training	degrees
Ankle inversion-eversion range of motion	Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training	degrees
Gait velocity during self-selected overground walking	Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training	cm/sec
Postural sway areas during quiet standing	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
Ratio of asymmetric loading in quiet standing	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
Push-off forces during gait initiation	Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training	Newtons; magnitude of forward ground reaction forces.

Trial Locations

Locations (1)

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States