Effects of Walking Analysis on Surgical Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00114075
First received: June 13, 2005
Last updated: July 17, 2012
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Procedure: Surgery with gait analysis report
Procedure: Surgery without gait analysis report
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Gait Analysis on Surgical Outcomes

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • Change in walking ability at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in walking efficiency at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in gross motor function at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in quality of life at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Additional treatment needed at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: January 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114075

Locations
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Shriners Hospital for Children, Los Angeles
Los Angeles, California, United States, 90020
Sponsors and Collaborators
Investigators
Principal Investigator: Tishya AL Wren, Ph.D. Children's Hospital Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00114075     History of Changes
Other Study ID Numbers: 5R01HS014169, 5R01HS014169
Study First Received: June 13, 2005
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
gait
walking
orthopedic surgery
orthopaedic surgery

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014