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

May 8, 2018 updated by: Charlene Elaine Hafer-Macko, Baltimore VA Medical Center
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center
        • Contact:
          • Kate C. Flores
        • Principal Investigator:
          • Charlene E. Hafer-Macko, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seated Ankle Robot Training
This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
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
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
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
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
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.
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
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
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
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
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

December 31, 2028

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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