Effects of Walking Analysis on Surgical Outcomes

July 17, 2012 updated by: Agency for Healthcare Research and Quality (AHRQ)

Impact of Gait Analysis on Surgical Outcomes

The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.

Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Childrens Hospital Los Angeles
      • Los Angeles, California, United States, 90020
        • Shriners Hospital for Children, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of cerebral palsy
  • Able to walk
  • Under evaluation for orthopedic surgery to correct walking problem(s)

Exclusion Criteria:

  • Orthopaedic surgery in past 1 year
  • Injection of botulinum toxin in past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait analysis
Gait analysis report is available for treatment planning
Procedure: Surgery with gait analysis report
Orthopaedic surgery with access to gait analysis report
Active Comparator: Control
Subject has gait analysis test, but report is not available for treatment planning
Procedure: Surgery without gait analysis report
Orthopaedic surgery without access to gait analysis report

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in walking ability at 1 year
Time Frame: 1 year
1 year
Change in walking efficiency at 1 year
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in gross motor function at 1 year
Time Frame: 1 year
1 year
Change in quality of life at 1 year
Time Frame: 1 year
1 year
Additional treatment needed at 1 year
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Tishya AL Wren, Ph.D., Children's Hospital Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 13, 2005

First Submitted That Met QC Criteria

June 13, 2005

First Posted (Estimate)

June 14, 2005

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01HS014169 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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