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Functional Electrical Stimulation for Footdrop in Hemiparesis

NCT00148343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-06-01

Study results available
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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.

Conditions

Interventions

DEVICE

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.

OTHER

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.

PROCEDURE

Traditional Physical Therapy Treatment

Traditional physical therapy treatment for 12 weeks.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Case Western Reserve University

    collaborator OTHER

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • John Chae, MD · MetroHealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-08-02
Completion
2010-08-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148343 on ClinicalTrials.gov