Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
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|ClinicalTrials.gov Identifier: NCT03530592|
Recruitment Status : Not yet recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nervous System Diseases Gait Disorders, Neurologic Foot Drop Mobility Limitation||Device: Seated Ankle Robot Training||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Seated Ankle Robot Taining|
|Masking:||None (Open Label)|
|Official Title:||Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 31, 2028|
|Estimated Study Completion Date :||December 31, 2028|
|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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530592
|Contact: Kate C. Flores||(410) firstname.lastname@example.org|
|United States, Maryland|
|Baltimore VA Medical Center|
|Baltimore, Maryland, United States, 21201|
|Contact: Kate C. Flores|
|Principal Investigator: Charlene E. Hafer-Macko, M.D.|
|Principal Investigator:||Charlene E. Hafer-Macko, M.D.||Baltimore VA Medical Center|