Clinical Trial: Ankle Robot to Reduce Foot-drop in Stroke
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Brief Summary: 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.
Detailed Summary:
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 investigator's 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:
- Independent gait function indexed by gait velocity, swing-phase DF, terminal stance push-off.
- Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, pe
Sponsor: VA Office of Research and Development
Current Primary Outcome:
- Gait velocity during self-selected overground walking [ Time Frame: change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]cm/sec
- Anterior-posterior propulsion forces of paretic side during gait [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]Newtons; force generated during push-off phase of the gait cycle
- Peak dorsiflexion angle during swing phase of gait [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]degrees; extent of ankle dorsiflexion to enable foot clearance
- Postural sway areas during quiet standing [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months 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 training, 6 weeks after completion of training, and 6 months after completion of training ]ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
- Peak paretic push off forces during gait initiation [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks aft
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: VA Office of Research and Development
Dates:
Date Received: June 19, 2015
Date Started: September 1, 2015
Date Completion: June 2019
Last Updated: April 26, 2017
Last Verified: April 2017
- Gait velocity during self-selected overground walking [ Time Frame: change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
