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Effects of Walking Analysis on Surgical Outcomes - Article


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Dejerine-Klumpke Palsy


Clinical Trial: Effects of Walking Analysis on Surgical Outcomes

This study is currently recruiting patients.

Sponsored by: Agency for Healthcare Research and Quality (AHRQ)
Information provided by: 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: Gait analysis (physical exam, 3-D kinematics/kinetics, EMG)
Phase II

MedlinePlus related topics:  Cerebral Palsy

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Impact of Gait Analysis on Surgical Outcomes

Further Study Details: 
Primary Outcomes: Change in walking ability at 1 year; Change in walking efficiency at 1 year
Secondary Outcomes: Change in gross motor function at 1 year; Change in quality of life at 1 year; Additional treatment needed at 1 year
Expected Total Enrollment:  240

Study start: January 2005;  Expected completion: June 2009
Last follow-up: April 2009;  Data entry closure: April 2009

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   -   18 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00114075


California
      Shriners Hospital for Children, Los Angeles, Los Angeles,  California,  90020,  United States; Recruiting
Gilda Robles, R.N.  213-639-3439    grobles@shrinenet.org 
Norman Otsuka, M.D.  213-368-3321    notsuka@shrinenet.org 
Norman Otsuka, M.D.,  Principal Investigator
Richard Bowen, M.D.,  Sub-Investigator

      Childrens Hospital Los Angeles, Los Angeles,  California,  90027,  United States; Not yet recruiting
Tishya AL Wren, Ph.D.  323-669-4120    twren@chla.usc.edu 
Robert M Kay, M.D.  323-669-4120    rkay@chla.usc.edu 
Tishya AL Wren, Ph.D.,  Principal Investigator
Robert M Kay, M.D.,  Sub-Investigator
Linda S Chan, Ph.D.,  Sub-Investigator

Study chairs or principal investigators

Tishya AL Wren, Ph.D.,  Principal Investigator,  Childrens Hospital Los Angeles   

More Information

Childrens Hospital Los Angeles Motion Analysis Laboratory

Agency for Healthcare Research and Quality

United Cerebral Palsy

Gait and Clinical Movement Analysis Society

Publications

Kay RM, Dennis S, Rethlefsen S, Reynolds RA, Skaggs DL, Tolo VT. The effect of preoperative gait analysis on orthopaedic decision making. Clin Orthop Relat Res. 2000 Mar;(372):217-22.

Study ID Numbers:  5R01HS014169; 5R01HS014169
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 13, 2005
ClinicalTrials.gov Identifier:  NCT00114075
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05


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October 13, 2008



Page Updated: September 6, 2005
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