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

Sponsor
Baltimore VA Medical Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT03530592
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
127
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Seated Ankle Robot Training
 N/A

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
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Seated Ankle Robot TainingSeated Ankle Robot Taining
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Seated Ankle Robot Training

Device: Seated Ankle Robot Training
This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.

Outcome Measures

Primary Outcome Measures

  1. Ankle dorsiflexion-plantarflexion range of motion [Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training]

    degrees

  2. Ankle inversion-eversion range of motion [Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training]

    degrees

  3. 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

  4. 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

  5. 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

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baltimore VA Medical Center Baltimore Maryland United States 21201

Sponsors and Collaborators

  • Baltimore VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charlene Elaine Hafer-Macko, Associate Professor of Neurology, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT03530592
Other Study ID Numbers:
  • HP-68734
First Posted:
May 21, 2018
Last Update Posted:
May 21, 2018
Last Verified:
May 1, 2018
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

Study Results

No Results Posted as of May 21, 2018