CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Odstock Dropped-Foot Stimulator (ODFS) +2 moredevice
Likely dose
Odstock Dropped-Foot Stimulator (ODFS) — device use for approximately 13 weeksAI-extracted
Key inclusion· 10
  • ✓Stroke survivors at least 90 days from most recent hemorrhagic or nonhemorrhagic stroke
  • ✓Age 18–80 years
  • ✓Unilateral hemiparesis (one-sided weakness)
  • ✓Medically stable
Key exclusion· 17
  • ✕Require an ankle-foot orthosis (AFO) to maintain knee stability during stance phase of gait
  • ✕Edema of the affected lower limb interfering with safe and effective use of the peroneal nerve stimulator
  • ✕Skin breakdown of the affected lower limb interfering with safe and effective use of the peroneal nerve stimulator
  • ✕Absent sensation of the affected lower limb

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00148343
NCT00148343N/ACompleted
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Functional Electrical Stimulation for Footdrop in Hemiparesis

MetroHealth Medical Center·interventional·Posted Sep 7, 2005·Updated Jun 1, 2018

In Brief

A clinical study evaluating Odstock Dropped-Foot Stimulator (ODFS), Conventional Standard of Care, and 1 other intervention for Stroke and Hemiplegia. Completed, enrolled 110 participants across 1 site.

Detailed Summary

The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors. The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Hemiplegia
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartJul 1, 2005
Primary CompletionAug 2, 2010
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago

Interventions

Odstock Dropped-Foot Stimulator (ODFS)device

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 Careother

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 Treatmentprocedure

Traditional physical therapy treatment for 12 weeks.