- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03530592
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kate C. Flores
- Phone Number: (410) 637-3242
- Email: kate.flores@va.gov
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center
-
Contact:
- Kate C. Flores
-
Principal Investigator:
- Charlene E. Hafer-Macko, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Charlene E. Hafer-Macko, M.D., Baltimore VA Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-68734
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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