What side effects are associated with this type of intervention?

Common side effects of rehabilitation treatments, including Immediate Weight Bearing as Tolerated (WBAT), can include pain, swelling, and discomfort at the site of injury. There is also a risk of re-injury or delayed healing if weight-bearing is initiated too early or performed incorrectly. Additionally, patients may experience muscle soreness and fatigue as they begin to mobilize and strengthen the affected area. In some cases, improper technique or overexertion can lead to complications such as hardware failure in surgically repaired fractures. It is crucial for patients to follow a structured rehabilitation program under professional supervision to minimize these risks.

What prior FDA approvals exist?

FDA approvals for rehabilitation treatments often focus on devices and therapies that promote early mobilization and weight-bearing to enhance healing and reduce complications. For instance, body-weight-supported treadmill training (BWSTT) has been studied for its effectiveness in improving cardiovascular fitness and walking ability post-stroke. Additionally, various physical therapy protocols and assistive devices are commonly used to facilitate early mobilization in patients recovering from fractures or surgeries. These approaches aim to accelerate recovery, improve functional outcomes, and minimize the risk of complications such as muscle atrophy and joint stiffness.

What other types of research exist?

Promising alternatives to Immediate Weight Bearing as Tolerated (WBAT) for rehabilitation patients include body-weight-supported treadmill training (BWSTT) and robotic-assisted BWSTT. These methods have shown potential in improving walking capacity, velocity, and quality of gait, which may enhance healing and reduce complications. Additionally, constraint-induced movement therapy (CIMT) and intensive motor function training are emerging as effective strategies for improving physical function in patients with various conditions.

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Immediate vs Delayed Weightbearing for Broken Bones

N/A

Waitlist Available

Led By Robert O'Toole, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following definitive fixation surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if patients with certain bone fractures can start using their injured leg or hip sooner than usual. It looks at immediate weight bearing versus waiting for a few weeks. The goal is to see if early use helps in healing without causing more problems.

Who is the study for?

This trial is for patients who've had surgery at specific Maryland medical centers within 7 days of a lower extremity, pelvis, or acetabulum fracture. They must understand the study and consent to participate. Excluded are non-English speakers, those with cognitive impairments without support, inability to weight bear immediately, unwillingness to be randomized or follow up issues.

What is being tested?

The study tests immediate versus delayed weight bearing after fixing fractures in the lower body. Patients will either start putting weight on their leg right away (WBAT) or wait for 6-12 weeks. The goal is to see if this approach is feasible before launching a larger trial.

What are the potential side effects?

Potential side effects aren't specified but may include complications from early weight bearing like increased pain, swelling, re-injury or hardware problems versus delayed healing and stiffness from waiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following definitive fixation surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following definitive fixation surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following definitive fixation 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

Repeat Surgery

Secondary study objectives

Percentage of patients who maintained follow-up

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Immediate WBATActive Control1 Intervention

Recent studies have highlighted that early WBAT is may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care has been delayed WBAT, but high-quality prospective studies on this topic are needed.

Group II: Delayed WBATActive Control1 Intervention

Though immediate postoperative WBAT has become the standard of care following fixation of pertrochanteric, femoral shaft, and tibial shaft fractures, most surgeons restrict patient weight bearing following fixation of other lower extremity and pelvis/acetabulum fractures. Progression to full weight bearing varies greatly by type of fracture, fixation method, and surgeon. Weight bearing restrictions following fracture fixation have been shown to be associated with various poor outcomes (increased complications, prolonged hospital length of stay, etc.), particularly in geriatric patients. Thus, it is important for us to understand if it is safe to allow early weight bearing following lower extremity and pelvis/acetabulum fracture fixation, as this could help expedite patient mobility and return to function, and potentially reduce complications.

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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

Early mobilization treatments like Immediate Weight Bearing as Tolerated (WBAT) work by promoting blood flow, reducing muscle atrophy, and improving joint mobility. These mechanisms enhance healing, reduce complications such as deep vein thrombosis, and lead to faster recovery times. For rehabilitation patients, these benefits are essential as they help restore independence and improve overall quality of life.

Effect of Compelled Body Weight Shift (CBWS) Therapy in Comparison to ProprioceptiveTraining on Functional Balance, Gait, andMuscle Strength Among Acute Stroke Subjects.The effect of a whole-body vibration therapy on the sitting balance of subacute stroke patients: a randomized controlled trial.Dual effects of body-weight supported treadmill training on cardiovascular fitness and walking ability early after stroke: a randomized controlled trial.