Effects of Walking Analysis on Surgical Outcomes

Cerebral Palsy Clinical Trial

Official title:

Impact of Gait Analysis on Surgical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114075
• Other study ID #: 5R01HS014169
• Secondary ID: 5R01HS014169
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2005
• Last updated: July 17, 2012
• Start date: January 2005
• Est. completion date: July 2010

Study information

• Verified date: August 2011
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Surgery with gait analysis report
Orthopaedic surgery with access to gait analysis report
• Surgery without gait analysis report
Orthopaedic surgery without access to gait analysis report

Locations

Country	Name	City	State
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Shriners Hospital for Children, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking ability at 1 year		1 year	No
Primary	Change in walking efficiency at 1 year		1 year	No
Secondary	Change in gross motor function at 1 year		1 year	No
Secondary	Change in quality of life at 1 year		1 year	No
Secondary	Additional treatment needed at 1 year		1 year	No

External Links

•   Agency for Healthcare Research and Quality
•   Gait and Clinical Movement Analysis Society
•   United Cerebral Palsy