CLINICAL TRIAL

Early Weight Bearing for Rehabilitation

Recruiting · 18+ · All Sexes · Madison, WI

This study is evaluating whether it is better to bear weight on an injured ankle right away or to wait.

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About the trial for Rehabilitation

Treatment Groups

This trial involves 2 different treatments. Early Weight Bearing is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Early Weight Bearing
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adults ages 18 or older
A fracture of the bimalleolar joint that requires fixation of two of the malleoli. show original
are indications for ORIF If you have a SER4 fracture (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation), then you should have surgery. show original
trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
If you have an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4), your doctor may recommend surgery to fix the fracture show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Early Weight Bearing will improve 2 primary outcomes and 4 secondary outcomes in patients with Rehabilitation. Measurement will happen over the course of 6 months.

Joint Range of Motion (ROM)
6 MONTHS
Joint range of motion (ROM) will be assessed using a plastic goniometer, an inexpensive device with two plastic arms that are aligned with relevant body segments to quickly provide joint angle information.
6 MONTHS
Pain Score
12 MONTHS
Pain will be measured using the Brief Pain Inventory (BPI) pain intensity domain at 3, 6 and 12 months. 27 The BPI pain intensity domain is compatible with the IMMPACT guidelines for assessing pain in clinical trials and the FDA Guidance for Industry on the use of Patient-Reported Outcome.
12 MONTHS
Self-Reported Measures of Function
12 MONTHS
Self-Reported Measures of Function will be assessed at 6 weeks and 3, 6 and 12 months post-injury using the Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Test (CAT) item banks, a product of the NIH Roadmap for Medical Research
12 MONTHS
Number of Study Related Complications Experienced
12 MONTHS
Re-admissions for a limb related issue and all re-operations on the study limb will be prospectively tracked by the Research Coordinators by routinely scanning hospital admission and orthopaedic surgery logs to identify all admissions and same day surgeries of patients actively enrolled in the study. Complications include loss of reduction and hardware failure, infection, non-union, malunion and fusion.
12 MONTHS
Return to Usual Major Activity and Work Productivity
12 MONTHS
Participants will be asked what they were doing most of the time during the previous two weeks (working/active duty, laid off/looking for work, going to school, taking care of a home, etc.). If participants are working, the Work Productivity and Activity Impairment (WPAI) questionnaire will be administered.The WPAI measures work time missed and work and activity impairment because of a specified health problem during the past 7 days (http://www.reillyassociates.net/WPAI_SHP.html).
12 MONTHS
Pain Interference
12 MONTHS
Pain will also be measured using the PROMIS Pain interference subscale. In addition, at each follow-up, the treating surgeon will also record the type and frequency of pain medications (grouped as acetaminophen, opioids, GABA analogues, NSAIDs and other).
12 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for rehabilitation?

At admission the in-hospital phase of rehabilitation is often inadequate, and is inversely related to in-hospital mortality. The lack of an assigned number of therapy sessions is a cause of inefficiency and uncoordinated care.

Anonymous Patient Answer

What is rehabilitation?

Rehabilitation and health psychology are important aspects of rehabilitation. Rehabilitation has a role in helping people, families, and staff of people with disability better cope and live independently. This can help those with a disability adjust to life post disability and to a better quality of life. Rehabilitation can also help people become more productive and more productive workers. Rehabilitation can also help to develop people's skills for more effective roles and meaningful work. Rehabilitation can also help prevent future disability.

Anonymous Patient Answer

What causes rehabilitation?

The rehabilitation needs of the older population are becoming increasingly apparent. This requires an in depth examination in order to better provide care and support in this challenging situation. This will allow more in depth discussions between families, professionals and patients.

Anonymous Patient Answer

How many people get rehabilitation a year in the United States?

Given the high financial cost of inpatient rehabilitation, there is a need for rehabilitation services to be integrated into the primary care setting. Further research is warranted on how effective and feasible this approach would be and, more broadly, what the implications would be for health care delivery.

Anonymous Patient Answer

What are the signs of rehabilitation?

These signs may include weakness, fatigue, and trouble sleeping. The rehabilitation process should commence early and encompass a multidisciplinary environment. The rehabilitator needs to be aware of the physical and psychosocial issues affecting the rehabilitation process and incorporate them into the rehabilitation program. Copyright 1999 Wiley-Liss, Inc.

Anonymous Patient Answer

Can rehabilitation be cured?

Patients at risk of reinjury are able to return to the same level of activity after 6 weeks postinjury, although a higher level of activity is necessary when the duration of inactivity is less than 6 weeks. Rehabilitation can be a successful treatment but cannot cure or prevent an injury from occurring.

Anonymous Patient Answer

What is the primary cause of rehabilitation?

The authors found that the primary causes of rehabilitation were (1) the symptoms related to the original disease; (2) the symptoms related to surgical wounds; and (3) the symptoms related to rehabilitation itself. The authors suggest that a better understanding of these factors will improve the effectiveness of rehabilitation.

Anonymous Patient Answer

Is early weight bearing typically used in combination with any other treatments?

Based on the current evidence from the last 25 years an early strategy on WB is highly recommended when treating patients with traumatic SCI. WB should occur from 12 to 24 weeks after SCI although it depends on the individual patient. Early passive stretching, aerobic exercise and WB are usually recommended.

Anonymous Patient Answer

Has early weight bearing proven to be more effective than a placebo?

Findings from a recent study found evidence that rehabilitation that includes early weight bearing exercises with a functional goal resulted in an improved functional return-to-work outcome. However, early weight bearing exercises do not improve short-term outcome for workers with musculoskeletal problems and can result in greater stress for the workplace as early re-workload is reintroduced. In this case, the best rehabilitation regimen should be selected based upon the patient's current status. Further studies are required to determine whether early weight bearing exercises are a valid therapeutic option for workers with musculoskeletal pain and disability.

Anonymous Patient Answer

Is early weight bearing safe for people?

Results from a recent paper, participants who received early weight bearing in total knee arthroplasty appeared to be more functionally mobile, were more physically active and showed reduced pain and swelling when compared to those who did not. This trial was not registered. Trials comparing early mobilisation versus standard of care post-arthroplasty were not reviewed in this study.

Anonymous Patient Answer

Have there been any new discoveries for treating rehabilitation?

[A 1991 study conducted on subjects in the US found that rehabilitation was one of the most commonly used treatments at that time. There were, however, many misconceptions about the benefits of rehabilitation. In the opinion of the authors, one of the most important elements of successful rehabilitation is an understanding and appreciation of the importance of the patient and family's perception of the situation, their needs and expectations. power.com/medicalrehabilitation/rehabilitation-at-home|here you will find new and enhanced resources to help you with your rehabilitation. The newest treatment available is the “Walking Stick” which is an aid for walking or standing that helps people keep their balance and mobility intact.

Anonymous Patient Answer

How does early weight bearing work?

In patients with a femoral fracture who received a locking plate, early full-weight bearing did not appear to impact hip strength. Patients who received fixed-angle plates, however, saw a trend toward faster strength regain that was likely attributable to the use of fixation.

Anonymous Patient Answer
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