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Effects of Walking Analysis on Surgical Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114075
First Posted: June 14, 2005
Last Update Posted: July 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Agency for Healthcare Research and Quality (AHRQ)
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Change in walking efficiency at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Change in gross motor function at 1 year [ Time Frame: 1 year ]
  • Change in quality of life at 1 year [ Time Frame: 1 year ]
  • Additional treatment needed at 1 year [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114075


Locations
United States, California
Shriners Hospital for Children, Los Angeles
Los Angeles, California, United States, 90020
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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 ( U.S. AHRQ Grant/Contract )
First Submitted: June 13, 2005
First Posted: June 14, 2005
Last Update Posted: July 18, 2012
Last Verified: August 2011

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