110
Participants
Start Date
July 31, 2005
Primary Completion Date
August 2, 2010
Study Completion Date
August 2, 2010
Odstock Dropped-Foot Stimulator (ODFS)
Device implementation \& use for \~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
Conventional Standard of Care
Conventional standard of care (which may include implementation \& use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for \~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
Traditional Physical Therapy Treatment
Traditional physical therapy treatment for 12 weeks.
MetroHealth Medical Center, Cleveland
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER