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Effects of Walking Analysis on Surgical Outcomes

Phase 2
Completed
Conditions
Cerebral Palsy
Registration Number
NCT00114075
Lead Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
186
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in walking ability at 1 year1 year
Change in walking efficiency at 1 year1 year
Secondary Outcome Measures
NameTimeMethod
Change in gross motor function at 1 year1 year
Change in quality of life at 1 year1 year
Additional treatment needed at 1 year1 year

Trial Locations

Locations (2)

Shriners Hospital for Children, Los Angeles

🇺🇸

Los Angeles, California, United States

Childrens Hospital Los Angeles

🇺🇸

Los Angeles, California, United States

Shriners Hospital for Children, Los Angeles
🇺🇸Los Angeles, California, United States

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