What this study is
The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.
What's being tested
- Wooden block
Intervention · DEVICE
Individuals randomized to this group will be given a wooden block at no cost to them and a simplified version of home, self-guided exercises with instructions on how to do the exercises and how often to do so.
- Formal physical therapy or Home Exercise Program
Intervention · OTHER
Individuals randomized to this group will receive the standard formal physical therapy which are sessions run by a physical therapist, usually 2-3 times a week to rehabilitate their ankle OR follow a standardized home exercise program which will be done by yourself with exercise outlined with how they should be performed and how often
Study details
- Official title
- Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol
- Sponsor
- University of Virginia
- Conditions
- Ankle Fractures · Pilon Fracture
- Enrolling
- 30 people
- Starts
- 2022-10-03
- Est. completion
- 2027-06-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Ages 18-65
- Surgically treated open or closed fractures of the ankle or tibial plafond
You can't join if
- Contralateral lower extremity injuries that would limit weight bearing after 6 weeks
- Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
- Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment
- Desire to participate in formal physical therapy program
- Additional injury that would compromise subjects ability to follow either Home Exercise Program
- Non ambulatory prior to injury
- Previous ankle or tibial plafond injury on ipsilateral extremity
- BMI > 50
- Severe problems maintaining follow up
- Previous ankle/tibial plafond fracture
- Prisoners
- Neurological impairments that impair balance
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Virginia Medical Center
Charlottesville, Virginia, United States
- Lori Elder · Contact434-924-8570LJE5U@uvahealth.org
Recruiting
Study team
Sponsor
University of Virginia
Study ID HSR200191
Principal investigator
Seth Yarboro, MD
University of Virginia Orthopaedic Surgey
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.