Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop

Summary

The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.

Conditions

• Sensorimotor Gait Disorder
• Neurologic Ambulation Disorder
• Gait, Drop Foot
• Poststroke Hemiparesis
• Post-Cerebrovascular Accident (CVA) Hemiparesis

Interventions

DEVICE

Ness L300

The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

DEVICE

Ankle-foot orthosis

The Control Group will walk with a "usual" ankle-foot orthosis (AFO).

Sponsors & Collaborators

• Medidata Solutions

  collaborator INDUSTRY

• University of Cincinnati

  collaborator OTHER

• Bioness Inc

  lead INDUSTRY

Principal Investigators

• Kari Dunning, PT, Ph.D · The Drake Center/University of Cincinnati

• Michael O'Dell, MD · Weill Medical College of Cornell University

• Patricia Kluding, PT, Ph.D. · University of Kansas

• Steven R. Edgley, MD · University of Utah

• Kathaleen P Brady, PT, NCS · MedStar National Rehabilitation Network

• Trevor Paris, MD · Brooks Rehabilitation

• Jerome Stenehjem, MD · Sharp Rehabilitation Center

• John Thottakara, MD · UT Southwestern

• Jun Zhang, MD · St. Charles Hospital & Rehabilitation

• Ziyad Ayyoub, MD · Rancho Los Amigos National Rehabilitation

• Diemha Hoang, MD · Long Beach Memorial Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2012-12-31

Completion

2013-02-28

Countries

• United States

Study Locations