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Behavioural Intervention

Post-Op Rehab Methods for Ankle and Pilon Fractures

N/A
Recruiting
Led By Seth Yarboro, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-65
Surgically treated open or closed fractures of the ankle or tibial plafond
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after surgery
Awards & highlights

Study Summary

This trial compares two post-op rehab methods to see which works best.

Who is the study for?
This trial is for individuals aged 18-65 who have had surgery to fix broken bones in the ankle or lower leg. It's not suitable for those with severe injuries needing complex reconstruction, balance issues due to neurological deficits, a high BMI over 50, previous similar injuries on the same side, or conditions that prevent weight-bearing after six weeks.Check my eligibility
What is being tested?
The study is testing if a simple home exercise program using a wooden block can match standard post-op rehab results for people recovering from ankle and lower leg fractures. Participants will either receive formal physical therapy or do exercises at home.See study design
What are the potential side effects?
Potential side effects may include discomfort during exercises, risk of re-injury if instructions aren't followed properly, and possible delayed healing if the simplified method isn't as effective as traditional therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I had surgery for a broken ankle or lower shin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle ROM
Ankle
Secondary outcome measures
Lower Extremity Functional Scale score
Ankle
Self reported subject compliance with exercise program: number of days completed

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Simplified block protocolExperimental Treatment1 Intervention
subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol
Group II: Usual careActive Control1 Intervention
Subjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,001 Total Patients Enrolled
Seth Yarboro, MDPrincipal InvestigatorUniversity of Virginia Orthopaedic Surgey
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Wooden block (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05280639 — N/A
Ankle Fracture Research Study Groups: Simplified block protocol, Usual care
Ankle Fracture Clinical Trial 2023: Wooden block Highlights & Side Effects. Trial Name: NCT05280639 — N/A
Wooden block (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280639 — N/A

Frequently Asked Questions

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

Is the minimum age for participants of this research project above twenty years old?

"According to the requirements for enrolment, potential participants must be above 18 years old and below 65."

Answered by AI

Is this research endeavor still searching for participants?

"According to details accessible on clinicaltrials.gov, this medical investigation is now enlisting suitable applicants; the trial was initially posted on October 3rd 2022 and most recently revised on May 18th 2023."

Answered by AI

What is the cap on participant numbers for this research project?

"Affirmative. According to clinicaltrials.gov, this research study is currently recruiting volunteers with the first posting on October 3rd 2022 and the most recent update being May 18th 2023. The project needs a total of 30 participants from one medical site."

Answered by AI

Is eligibility for this medical study restricted to certain individuals?

"This research study is enrolling 30 participants who have suffered a pilon fracture and are between18 and 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
Seth Yarboro, MD 2022. "Simplified Post Op Rehabilitation for Ankle and Pilon Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280639.
~5 spots leftby Sep 2024
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