Recruiting

Post Op Rehabilitation

Sponsor:

University of Virginia

Code:

NCT05280639

Conditions

Ankle Fractures

Pilon Fracture

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Wooden block

Formal physical therapy or Home Exercise Program

Study Details

Brief summary:

The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.

Conditions

Ankle Fractures

Pilon Fracture

Study ID

NCT05280639

Start date

Oct 3, 2022

Status verified date

Jun, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 18-65
  • Surgically treated open or closed fractures of the ankle or tibial plafond

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Simplified block protocol

subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol

active comparator: Usual care

Subjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.

Interventions

Wooden block

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

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

Primary outcome measure

  • Ankle Range of Motion (ROM) [ Time Frame: 2 weeks after surgery ]
  • Ankle ROM [ Time Frame: 6 weeks after surgery ]
  • Ankle ROM [ Time Frame: 6 months after surgery ]

Central Contacts and Locations

Central contacts

Eric McVey, MEd

434.243.5382edm9u@hscmail.mcc.virginia.edu

Locations

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Lori Elder

434-924-8570LJE5U@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-08.