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Clinical Trials/NCT03530592
NCT03530592Not yet recruitingNot Applicable

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

Baltimore VA Medical Center1 site in 1 country100 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
Ankle dorsiflexion-plantarflexion range of motion

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 88 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Seated Ankle Robot Training

Experimental

Intervention: Seated Ankle Robot Training (Device)

Outcomes

Primary Outcomes

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

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

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

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

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Charlene Elaine Hafer-Macko

Associate Professor of Neurology

Baltimore VA Medical Center

Study Sites (1)

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