Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function

NCT01336517 | Completed

• 1 other identifier: E59007
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

Conditions

Hemiplegia, Spastic

Keywords

Stroke; Hemiplegia; AFO; Gait

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and 75, who are greater than 6 months post and have been prescribed a custom molded AFO for assistance with gait deviations

You may qualify if:

• Between the ages of 18 and 75
• Have sustained a stroke at least 6 months prior to study enrollment
• Use a prescribed custom brace while walking
• Have no history of injury, orthopedic or other medical problem in the normal leg
• Be able to walk independently or with close supervision for 25 feet without a brace or cane
• Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens

You may not qualify if:

• Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
• Neurological illness, history, or conditions that my interfere with walking except for stroke
• Psychiatric conditions or history that would interfere with the ability to walk or follow directions
• Serious lung or heart condition that could severely limit the ability to walk

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karen Nolan, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: April 18, 2011
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 18, 2011

Record last verified: 2011-04

Locations

US (1)