Ankle Robot to Reduce Foot Drop in Stroke
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|ClinicalTrials.gov Identifier: NCT02483676|
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke Foot Drop||Device: Treadmill plus anklebot Behavioral: Treadmill only||Not Applicable|
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:
- 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, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
- Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke|
|Actual Study Start Date :||September 1, 2015|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||June 30, 2019|
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
Device: Treadmill plus anklebot
This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Other Name: TMR
Active Comparator: Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
Behavioral: Treadmill only
This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Other Name: TM
- 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 after completion of training, and 6 months 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): NCT02483676
|Contact: Kate C Flores||(410) firstname.lastname@example.org|
|Contact: Anindo Roy, PhD||(410) email@example.com|
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Richard F Macko 410-605-7000 ext 5413 Richard.Macko@va.gov|
|Contact: Anindo Roy, PhD (410) 200-0894 firstname.lastname@example.org|
|Sub-Investigator: Larry W Forrester, PhD|
|Principal Investigator: Richard F Macko|
|Principal Investigator:||Richard F Macko||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|