What side effects are associated with this type of intervention?

Common treatments for ankle fractures include immobilization with a cast or brace, physical therapy, and in some cases, surgical intervention. Side effects of these treatments can include stiffness, swelling, and pain at the fracture site. For treatments similar to the simplified wooden block stretching protocol, which involves stretching exercises, potential side effects may include muscle soreness, temporary increase in pain, and risk of overstretching leading to ligament or tendon injury. It is important to perform these exercises under the guidance of a healthcare professional to minimize risks.

What prior FDA approvals exist?

The FDA has approved various treatments for ankle fractures, primarily focusing on surgical interventions, immobilization techniques, and physical therapy. While specific FDA approvals for rehabilitation protocols like the Simplified Wooden Block Stretching Protocol are not detailed, physical therapy and structured exercise regimens are commonly recommended post-surgery to restore mobility and strength. These regimens often include stretching and strengthening exercises, which can be similar to the wooden block stretching exercises being studied.

What other types of research exist?

Promising alternatives to the Simplified Wooden Block Stretching Protocol for ankle fracture patients include: 1) Low-intensity pulsed ultrasound therapy, which has been shown to accelerate ligament healing. 2) Prophylactic knee bracing, which can provide support and prevent further injury. 3) Complete decongestive physical therapy, which is effective in managing secondary lymphedema and improving overall limb function. 4) Intermittent pneumatic compression, which has been shown to improve quality of life and reduce swelling in lower extremity conditions.

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Behavioural Intervention

Post-Op Rehab Methods for Ankle and Pilon Fractures

N/A

Recruiting

Led By Seth Yarboro, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-65

Surgically treated open or closed fractures of the ankle or tibial plafond

Must not have

Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)

Non-ambulatory prior to injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial compares standard post-surgery rehabilitation with a new wooden block stretching protocol for patients with ankle fractures. The goal is to see if the simpler wooden block exercises can effectively reduce stiffness and improve ankle movement. The study will measure pain, compliance, and ankle function over several follow-up periods.

Who is the study for?

This trial is for individuals aged 18-65 who have had surgery to fix broken bones in the ankle or lower leg. It's not suitable for those with severe injuries needing complex reconstruction, balance issues due to neurological deficits, a high BMI over 50, previous similar injuries on the same side, or conditions that prevent weight-bearing after six weeks.

What is being tested?

The study is testing if a simple home exercise program using a wooden block can match standard post-op rehab results for people recovering from ankle and lower leg fractures. Participants will either receive formal physical therapy or do exercises at home.

What are the potential side effects?

Potential side effects may include discomfort during exercises, risk of re-injury if instructions aren't followed properly, and possible delayed healing if the simplified method isn't as effective as traditional therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I had surgery for a broken ankle or lower shin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe injury needing special surgery to cover the wound or fix blood vessels.

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I was unable to walk before my injury.

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I cannot stand safely on my own for exercises due to neurological issues.

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I have had a previous ankle or lower leg fracture.

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I have balance issues due to a neurological condition.

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I have had a previous injury to my ankle or the lower part of my shin on the same side.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ankle ROM

Ankle

Secondary study objectives

Lower Extremity Functional Scale score

Ankle

Self reported subject compliance with exercise program: number of days completed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simplified block protocolExperimental Treatment1 Intervention

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

Group II: Usual careActive Control1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ankle fractures include immobilization, surgical intervention, and post-operative rehabilitation. Immobilization, using casts or braces, stabilizes the fracture to allow proper bone healing. Surgical intervention, such as internal fixation, aligns and secures bone fragments. Post-operative rehabilitation, including stretching exercises like the simplified wooden block protocol, is crucial for restoring range of motion, strength, and function. These exercises work by gradually stretching and strengthening the muscles and tendons around the ankle, promoting flexibility and reducing stiffness. This is particularly important for ankle fracture patients to regain mobility, prevent long-term complications, and ensure a return to normal activities.