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.
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
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Lori Elder, 434-924-8570, LJE5U@uvahealth.org
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.
- Conditions
- Ankle Fractures, Pilon Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Simplified block protocol | Experimental | subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol Receives: Device: Wooden block |
| Usual care | Active comparator | Subjects 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.
Ankle Range of Motion (ROM)
maximum plantarflexion and maximum dorsiflexion
Measured: 2 weeks after surgery
Ankle ROM
maximum plantarflexion and maximum dorsiflexion
Measured: 6 weeks after surgery
Ankle ROM
maximum plantarflexion and maximum dorsiflexion
Measured: 6 months after surgery
Secondary outcomes (8)
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
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
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.
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.
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.
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
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
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.
- First posted15 Mar 2022
- Study start3 Oct 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Yarboro, MD, University of Virginia
- Investigators
- Seth Yarboro, MD, Principal investigator, University of Virginia Orthopaedic Surgey
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol
- ClinicalTrials.gov ID
- NCT05280639
- Acronym / sponsor ID
- HSR200191
- Conditions
- Ankle Fractures, Pilon Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified block protocol | Experimental | Device: Wooden blocksubjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol |
| Usual care | Active comparator | Other: Formal physical therapy or Home Exercise ProgramSubjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-65
- Surgically treated open or closed fractures of the ankle or tibial plafond
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wooden blockIndividuals 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. | Device | Simplified block protocol |
| Formal physical therapy or Home Exercise ProgramIndividuals 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 | Other | Usual care |
Primary outcome
Ankle Range of Motion (ROM)
Time frame: 2 weeks after surgery
maximum plantarflexion and maximum dorsiflexion
Ankle ROM
Time frame: 6 weeks after surgery
maximum plantarflexion and maximum dorsiflexion
Ankle ROM
Time frame: 6 months after surgery
maximum plantarflexion and maximum dorsiflexion
8 secondary outcomes
Self reported subject compliance with exercise program: number of days completed
Time frame: 2 weeks after surgery
Self reported subject compliance with exercise program: number of days completed
Time frame: 6 weeks after surgery
Lower Extremity Functional Scale score
Time frame: 2 weeks after surgery.
Lower Extremity Functional Scale score
Time frame: 6 weeks after surgery.
Lower Extremity Functional Scale score
Time frame: 6 months after surgery.
Pain and ankle Range of Motion
Time frame: 2 weeks after surgery
Pain and ankle Range of Motion
Time frame: 6 weeks after surgery
Pain and ankle Range of Motion
Time frame: 6 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seth Yarboro, MD principal investigator
University of Virginia Orthopaedic Surgey
1 site in 1 country: see every site and its status.
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.