Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Virginia
About this trial
The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-65
Surgically treated open or closed fractures of the ankle or tibial plafond
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Wooden block
DeviceIndividuals 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
Other interventionIndividuals 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
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Simplified block protocolExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ankle Range of Motion (ROM)
maximum plantarflexion and maximum dorsiflexion
Time frame
2 weeks after surgery2
Ankle ROM
maximum plantarflexion and maximum dorsiflexion
Time frame
6 weeks after surgery3
Ankle ROM
maximum plantarflexion and maximum dorsiflexion
Time frame
6 months after surgerySecondary outcomes
1
Self reported subject compliance with exercise program: number of days completed
Comparison of compliance between a full American Academy of Orthopaedic Surgeons (AAOS) home exercise program/formal physical therapy visits and the simplified ankle dorsiflexion with a wooden block
Time frame
2 weeks after surgery2
Self reported subject compliance with exercise program: number of days completed
Comparison of compliance between a full AAOS home exercise program/formal physical therapy visits and the simplified ankle dorsiflexion with a wooden block
Time frame
6 weeks after surgery3
Lower Extremity Functional Scale score
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Time frame
2 weeks after surgery.4
Lower Extremity Functional Scale score
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Time frame
6 weeks after surgery.Sponsors and contacts
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Source ClinicalTrials.gov