Effects of Walking Analysis on Surgical Outcomes
Impact of Gait Analysis on Surgical Outcomes
1 other identifier
interventional
186
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2005
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 13, 2005
CompletedFirst Posted
Study publicly available on registry
June 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 18, 2012
August 1, 2011
5.5 years
June 13, 2005
July 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in walking ability at 1 year
1 year
Change in walking efficiency at 1 year
1 year
Secondary Outcomes (3)
Change in gross motor function at 1 year
1 year
Change in quality of life at 1 year
1 year
Additional treatment needed at 1 year
1 year
Study Arms (2)
Gait analysis
EXPERIMENTALGait analysis report is available for treatment planning
Control
ACTIVE COMPARATORSubject has gait analysis test, but report is not available for treatment planning
Interventions
Orthopaedic surgery with access to gait analysis report
Orthopaedic surgery without access to gait analysis report
Eligibility Criteria
You may qualify if:
- Diagnosis of cerebral palsy
- Able to walk
- Under evaluation for orthopedic surgery to correct walking problem(s)
You may not qualify if:
- Orthopaedic surgery in past 1 year
- Injection of botulinum toxin in past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shriners Hospital for Children, Los Angeles
Los Angeles, California, 90020, United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
Related Publications (1)
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. doi: 10.1097/00003086-200003000-00023.
PMID: 10738430BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tishya AL Wren, Ph.D.
Children's Hospital Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2005
First Posted
June 14, 2005
Study Start
January 1, 2005
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 18, 2012
Record last verified: 2011-08