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Observational Analysis with Gait Lab Information for Cerebral Palsy
N/A
Waitlist Available
Led By Unni Narayanan, MBBS, MSc, FRCSC
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12, 24 months follow up
Awards & highlights
Study Summary
This trial is testing whether using a gait lab to help plan surgery for children with cerebral palsy results in better outcomes than just observing them.
Eligible Conditions
- Cerebral Palsy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6, 12, 24 months follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12, 24 months follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
General Effect Size of
Secondary outcome measures
Activity Scale for Kids (ASK)
Functional Mobility Scale (FMS)
Gait Parameters
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group B (additional pre-operative analysis)Experimental Treatment1 Intervention
Group II: Group A (standard pre-operative analysis)Active Control1 Intervention
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
692 Previous Clinical Trials
6,946,540 Total Patients Enrolled
11 Trials studying Cerebral Palsy
4,638 Patients Enrolled for Cerebral Palsy
Unni Narayanan, MBBS, MSc, FRCSCPrincipal InvestigatorThe Hospital for Sick Children, Toronto Canada
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have trouble walking that makes it hard for you to do things.You are planning to have surgery on at least two levels in one or both of your lower limbs, such as the knee and ankle.You need to be able to have a specialized walking analysis done in a motion lab.You have conditions that cause muscle tone abnormalities.You have had surgery on your legs or feet in the past 2 years.You have already had a gait laboratory analysis reviewed by the surgeon treating you.You have been diagnosed with spastic cerebral palsy.You are between 6 and 15 years old when the study starts.You have moderate to severe difficulty with walking, and may or may not need help from braces or walking aids.You are seeking treatment for walking problems.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (standard pre-operative analysis)
- Group 2: Group B (additional pre-operative analysis)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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