The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST) trial for stroke: study design and protocol

Abstract

Kari Dunning,1 Michael O'Dell,2 Patricia Kluding,3 Samuel S Wu,4 Jody Feld,5 Jivan Ginosian,6 Keith McBride61Department of Rehabilitation Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, 2Department of Rehabilitation Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, 3Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS, 4Department of Biostatistics, University of Florida, Gainesville, FL, 5Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC, 6Bioness Inc, Valencia, CA, USABackground: Surface electrical stimulation for foot drop (foot drop stimulation [FDS]) technology has greatly improved over the last decade, leading to increased use in the clinic environment and the community. Despite numerous studies suggesting the benefit of FDS among persons with stroke, there are no randomized controlled trials comparing FDS to standard of care (ankle foot orthosis [AFO]). The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST) study is a single-blinded randomized controlled trial with the primary purpose of comparing FDS and AFO among persons with stroke conducted at eleven sites throughout the USA.Methods: Persons ≥ 3 months poststroke are randomized to wear either FDS or AFO for 30 weeks. After 30 weeks, AFO participants crossover to wear an FDS. All participants are followed for 42 weeks with repeated measures at baseline and Weeks 6, 12, 30, 36, and 42. The primary analysis will compare gait speed between FDS and AFO at 30 weeks. Secondary outcomes span the International Classification of Functioning, Disability, and Health categories and include functional gait, balance, motor control, falls, and quality of life. Tertiary analyses will be performed using Weeks 36 and 42 time points.Conclusion: This pivotal trial is the first longitudinal randomized controlled trial to compare FDS and AFO in persons with stroke. Further, the results will be the largest single contribution to date on the efficacy of FDS in people with stroke, providing a robust dataset with findings that can be extrapolated for use as guidelines to clinical practice.Trial registration: clinicaltrials.gov NCT01138995.Keywords: electrical stimulation, stroke, cerebrovascular accident, rehabilitation, foot drop stimulation, gait