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Ankle FracturesNCT05280639

Simplified Post Op Rehabilitation for Ankle and Pilon Fractures

A study testing Wooden block and Formal physical therapy or Home Exercise Program in people with Ankle Fractures and Pilon Fracture, run by University of Virginia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankle Fractures, Pilon Fracture
What is being tested?
Wooden block and Formal physical therapy or Home Exercise Program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
3 Oct 2022to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

    Lori Elder, 434-924-8570, LJE5U@uvahealth.org

    Recruiting

Other trials in United States

About this study

Official title: Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol

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

Read the detailed description

Ankle fractures and pilon fractures represent common injuries in orthopedics. These injuries are addressed with re-aligning the bones with surgery, and in some particular cases, they are treated closed reduction and immobilization during healing. The trauma to the ankle as a result of the injury, the prolonged immobilization in a cast or splint and the scar tissue formed during surgery often lead to post injury and post-operative stiffness. Many patients have limited ability to flex the ankle upward (dorsiflexion) following cast or splint removal for these injuries. Physical therapy and rehabilitation represent an an industry-accepted practice for alleviating stiffness and improving function. Currently there are varying studies on the benefits of manual therapy or passive stretch when compared with exercise alone. Neither a supervised exercise program such as formal physical therapy nor a home exercise regiment offer a clear benefit over the other, leading to the question of, if this process can be further simplified to use with the wooden block.

The main functional complaint of patients is "stiffness" or decreased range of motion is in dorsiflexion of the ankle and is cited at approximately 77% of patients following cast or splint removal. This motion is key when walking normally, descending stairs or kneeling and is important to a greater degree when walking up hills , running or rising from a chair. These activities require 10 degrees passive dorsiflexion and 20 degrees on average, respectively. The functional effects of limited ankle dorsiflexion sometimes results in the need for a shoe heel insert or additional surgical procedures to free up the scar in the front of the ankle.

This randomized control trial aims to analyze two currently-used standards of care for ankle and tibial plafond injuries, simplifying the standard post-operative physical therapy/rehabilitation regiment, which would begin a the time of rigid splint removal, when stretching and range of motion is tolerated. Weight bearing with ambulation is slowly adjusted for the weeks following this. This simplified wooden block protocol ankle exercises focus strictly on ankle dorsiflexion using a wooden block. The investigators aim of doing so is to increase compliance with the exercises and with an improved functional outcome as compared with the standard, more complex exercises and time burdensome options.

The aim of this study is to compare the standard post injury/surgery rehabilitation with this new simplified wooden block stretching protocol and analyze the simplified protocol's effectiveness verses other industry accepted exercises/therapy regiments. This study will evaluate pain scores, compliance, range of motion of the ankle and include a Lower Extremity Functionality Score survey, over the course of 3 standard post-operative visits following the subjects injury.

Being tested
Wooden block, Formal physical therapy or Home Exercise Program
Medical subject headings
Ankle Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wooden blockDevice

    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 ProgramOther

    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 groups in NCT05280639
Study groupRoleWhat they receive
Simplified block protocolExperimentalsubjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol
Receives: Device: Wooden block
Usual careActive comparatorSubjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.
Receives: Other: Formal physical therapy or Home Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ankle Range of Motion (ROM)

    maximum plantarflexion and maximum dorsiflexion

    Measured: 2 weeks after surgery

  2. Ankle ROM

    maximum plantarflexion and maximum dorsiflexion

    Measured: 6 weeks after surgery

  3. Ankle ROM

    maximum plantarflexion and maximum dorsiflexion

    Measured: 6 months after surgery

Secondary outcomes (8)
  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

    Measured: 2 weeks after surgery

  2. 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

    Measured: 6 weeks after surgery

  3. 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.

    Measured: 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.

    Measured: 6 weeks after surgery.

  5. 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.

    Measured: 6 months after surgery.

  6. Pain and ankle Range of Motion

    Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.

    Measured: 2 weeks after surgery

  7. Pain and ankle Range of Motion

    Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.

    Measured: 6 weeks after surgery

  8. Pain and ankle Range of Motion

    Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.

    Measured: 6 months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start3 Oct 2022
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280639
Sponsor's protocol ID
HSR200191
Status last verified
Jun 2026
First submitted
28 Sep 2021
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Wooden block and Formal physical therapy or Home Exercise Program in people with Ankle Fractures and Pilon Fracture, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric McVey, MEd (434.243.5382, edm9u@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankle Range of Motion (ROM) (time frame: 2 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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