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Efficacy of the WalkAide and AFOs for CVA

NCT00216320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2013-04-19

Study results available
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Summary

To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop. The comparison will involve physical measurements (e.g. walking speed, physiological cost index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and acceptance of the technology by stroke survivors.

Conditions

Interventions

DEVICE

WalkAide

Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks

DEVICE

AFO

Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks

DEVICE

AFO

Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover

Sponsors & Collaborators

  • Innovative Neurotronics

    lead INDUSTRY

Principal Investigators

  • Michael C Munin, MD · University of Pittsburgh, Department of PM&R

  • Sunil Hegde, MD · Huntington Rehabilitation Medicine Associates

  • Gerard Francisco, MD · Texas Institute of Rehabilitation Research

  • Richard Herman, MD · Good Samaritan Rehabilitation Institute

  • Thy Huskey, MD · Washington University in St. Louis, Department of Neurology

  • Gary Abrams, MD · University of California; San Francisco VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-11-30
Completion
2008-11-30

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 NCT00216320 on ClinicalTrials.gov