Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
NCT Number: NCT02483676
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Other names: TMR
This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Other names: TM
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Gait velocity during self-selected overground walking measured in cm/sec
Time frame: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Degrees; extent of ankle dorsiflexion to enable foot clearance
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
cm^2; extent of postural deviations to assess static postural control
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Newtons; magnitude of forward ground reaction forces
VA Office of Research and Development
Fed
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
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