Effects of Walking Analysis on Surgical Outcomes

Study Overview
=================
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.

Official Title
-----------------
Impact of Gait Analysis on Surgical Outcomes

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: Surgery with gait analysis report
* Procedure: Surgery without gait analysis report


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait analysis<br>Gait analysis report is available for treatment planning | Procedure: Surgery with gait analysis report<br>* Orthopaedic surgery with access to gait analysis report<br>|
| Active Comparator: Control<br>Subject has gait analysis test, but report is not available for treatment planning | Procedure: Surgery without gait analysis report<br>* Orthopaedic surgery without access to gait analysis report<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking ability at 1 year |  | 1 year | 
| Change in walking efficiency at 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gait, walking, orthopedic surgery, orthopaedic surgery