Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Primary Purpose
Foot Drop, Peripheral Nervous System Diseases, Gait Disorders, Neurologic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill Ankle Robot Training
Sponsored by
About this trial
This is an interventional treatment trial for Foot Drop
Eligibility Criteria
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:
- 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
- Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments)
- 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
- Current participation in orthopedic or rehabilitation medical programs
- Active deep venous thrombosis
- Distal paretic leg skin lesions, infections, or soft tissue inflammation
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treadmill Ankle Robot Training
Arm Description
Outcomes
Primary Outcome Measures
Gait velocity during self-selected overground walking
cm/sec
Peak dorsiflexion angle during swing phase of gait
degrees; extent of ankle dorsiflexion to enable foot clearance
Ankle dorsiflexion-plantarflexion range of motion
degrees
Postural sway areas during quiet standing
cm^2; extent of postural deviations to assess static postural control
Ratio of asymmetric loading in quiet standing
ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Push-off forces during gait initiation
Newtons; magnitude of forward ground reaction forces.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03556709
Brief Title
Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Official Title
Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Drop, Peripheral Nervous System Diseases, Gait Disorders, Neurologic, Mobility Limitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treadmill Ankle Robot Training
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Treadmill Ankle Robot Training
Intervention Description
This intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.
Primary Outcome Measure Information:
Title
Gait velocity during self-selected overground walking
Description
cm/sec
Time Frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Title
Peak dorsiflexion angle during swing phase of gait
Description
degrees; extent of ankle dorsiflexion to enable foot clearance
Time Frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Title
Ankle dorsiflexion-plantarflexion range of motion
Description
degrees
Time Frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Title
Postural sway areas during quiet standing
Description
cm^2; extent of postural deviations to assess static postural control
Time Frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Title
Ratio of asymmetric loading in quiet standing
Description
ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Time Frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Title
Push-off forces during gait initiation
Description
Newtons; magnitude of forward ground reaction forces.
Time Frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments)
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
Current participation in orthopedic or rehabilitation medical programs
Active deep venous thrombosis
Distal paretic leg skin lesions, infections, or soft tissue inflammation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate C. Flores
Phone
(410) 637-3242
Email
kate.flores@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlene E. Hafer-Macko, M.D.
Organizational Affiliation
Baltimore VA Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
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