Does the use of gait analysis for decision making, improve outcomes of surgery for children with cerebral palsy?

Not Applicable

Completed

• Conditions: Cerebral palsy; Nervous System Diseases

• Registration Number: ISRCTN51084195
• Lead Sponsor: Bloorview Kids Rehab (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-08
• Study Completion: 2013-08-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Diagnosis of spastic cerebral palsy
2. Age 6 to 15 years at the time of the initial assessment, either sex
3. Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices)
4. Patients have been referred for assessment and treatment of gait abnormality
5. Patients have a gait abnormality interfering with their physical function
6. Patients are candidates for orthopaedic surgery including soft tissue and/or bony procedures involving at least 2 levels, in one or both lower extremities (e.g. knee and ankle)
7. Patients must be able to undergo instrumented gait analysis testing in a motion laboratory

Exclusion Criteria

1. Presence of dystonia, athetosis, or mixed tone abnormalities
2. History of orthopaedic lower extremity procedures within the previous 2 years
3. Patients who have had previous gait laboratory analysis that has been seen by the treating surgeon
4. Patients who will be unable to return for the required follow up visits/gait analysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Gross Motor Function Measure (GMFM-66)<br> 2. Gillette Gait (Normalcy) Index (GGI)<br> 3. Pediatric Outcomes Data Collection Instrument (PODCI)<br> 4. Functional Assessment Questionnaire (FAQ)<br> 5. Functional Mobility Scale (FMS)<br> 6. Activities Scale for Kids (ASK-performance)<br> 7. Gait Parameters: gait velocity and stride length<br><br> The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for the definitive trial<br>

Secondary Outcome Measures

Name	Time	Method
<br> Consistency of Surgeons' Decision Making: intra- and inter-rater reliability<br><br> The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for the definitive trial<br>