Walking How-To's |
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Clinical Trial: Effects of Walking Analysis on Surgical Outcomes
This study is currently recruiting patients.
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Purpose
| 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
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
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
California
Shriners Hospital for Children, Los Angeles, Los Angeles, California, 90020, United States; Recruiting
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
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
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.
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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