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Dynamic bar for Clubfoot

N/A
Waitlist Available
Led By Maryse Bouchard, MD
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
Well-corrected clubfoot/clubfeet (Pirani score ≤ 0.5)
Diagnosis of idiopathic clubfoot (unilateral or bilateral).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial is evaluating a new dynamic bar for foot abduction bracing for clubfoot treatment. Eligible patients must have a well-corrected idiopathic clubfoot and be in the minimum 12 hours per day bracing stage of the Ponseti clubfoot treatment protocol. The overall study period will be 90 days in length.

Eligible Conditions
  • Clubfoot

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your clubfoot has been successfully treated and corrected by a doctor.
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You have been diagnosed with clubfoot without a known cause (on one or both feet).
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You are currently receiving Ponseti treatment and wearing a brace for at least 12 hours a day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of recruitment for a prospective trial comparing clubfoot brace types.
Retention of patients for a prospective trial comparing clubfoot brace types.
Secondary outcome measures
Parent perception of child comfort in brace
Patient tolerance of brace based on hours brace worn
Other outcome measures
Preliminary assessment of brace effectiveness

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dynamic barExperimental Treatment1 Intervention
This group will use the novel dynamic bar for 30 days instead of their standard straight bar.
Group II: Straight barActive Control1 Intervention
This group will continue using the straight bar as part of their brace, per their current treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Foot abduction bracing for clubfoot with novel dynamic bar
2022
N/A
~20

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
682 Previous Clinical Trials
6,945,323 Total Patients Enrolled
Maryse Bouchard, MDPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants who are above the age of 20?

"This trial is enrolling participants between the ages of 1 and 3 years old."

Answered by AI

Is this experiment actively seeking participants?

"According to clinicaltrials.gov, this study is accepting applicants as of now. The trial was initially put forward on July 5th 2022 and has been amended most recently on October 21st 2022."

Answered by AI

How many participants are currently engaging in this research?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical investigation is currently recruiting participants for its inaugural cohort. First posted on July 5th 2022 and most recently updated October 21st 2022, the trial requires 20 volunteers from a single research facility."

Answered by AI

Who is qualified to partake in this experiment?

"This clinical trial is seeking 20 toddlers aged between one and three who are diagnosed with clubfoot. To be eligible, the parent/caregiver must have a grasp of English to complete brace wear log/surveys, as well as meet other criteria such as current use of a standard SB with their Foot Abduction Brace., being in the minimum 12-hour per day bracing stage of Ponseti treatment, having a Pirani score ≤ 0.5, and enrolling in the SickKids Clubfoot Research Registry.."

Answered by AI
~4 spots leftby Mar 2025