Preoperative Mobility Device Training for Reducing Postoperative Falls

Overseen By Ashish B Shah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Wheelchair-bound, Cognitive impairment, Mobility impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether preoperative mobility device training is beneficial in reducing incidence of postoperative falls in patients undergoing elective foot and ankle surgery requiring a postoperative period of no weight-bearing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of preoperative mobility device training for reducing postoperative falls?

Research shows that preoperative education and exercise programs can lead to better outcomes after surgery, such as shorter hospital stays and improved mobility. For example, patients who participated in preoperative physical therapy and education had shorter hospital stays and were more likely to walk independently after joint surgery. ^{1 2 3 4 5}

Is preoperative mobility device training safe for humans?

Research on preoperative exercise and mobility training suggests it is generally safe and can improve recovery after surgery. Studies highlight the importance of structured exercise programs to enhance patient fitness and reduce complications, though more research is needed to optimize these programs for different conditions. ^{6 7 8 9 10}

How does preoperative mobility device training differ from other treatments for reducing postoperative falls?

Preoperative mobility device training is unique because it focuses on educating patients on the use of mobility aids before surgery, which can help ensure safe movement and protect the operated area post-surgery. This proactive approach is different from other treatments that may not emphasize pre-surgery preparation and education, potentially leading to better postoperative outcomes and reduced fall risk. ^{3 7 8 11 12}

Research Team

Ashish B. Shah, M.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 who need elective foot or ankle surgery and will have to avoid putting weight on it afterward. It's not for those under 18, wheelchair users, people who've used mobility devices after surgery before, those having surgery on both feet/ankles at once, needing follow-ups beyond 6 weeks, with ankle fractures or pre-existing cognitive/balance/mobility issues.

Inclusion Criteria

I am scheduled for foot or ankle surgery on one side.

I am 18 years old or older.

My surgeon advised me not to put weight on my operated area for a while.

Exclusion Criteria

patients requiring follow ups longer than 6 weeks

I have an ankle fracture or a condition affecting my thinking, balance, or ability to move.

I am having surgery on both sides of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Training

Participants in Group 1 receive preoperative mobility device training during their standard pre-operative care

1 visit

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo foot and ankle surgery and receive standard postoperative care

Immediate postoperative period

Follow-up

Participants are monitored for falls during routine 2-week and 6-week follow-up visits

6 weeks

2 visits (in-person)

Treatment Details

Interventions

• Preoperative mobility device(s) training

Trial Overview The study tests if teaching patients how to use mobility aids before their foot or ankle surgery can help prevent falls after the operation when they can't put weight on their foot. Participants are trained in using these devices prior to their scheduled surgeries.

Participant Groups

Group I: Mobility Device Training Group Active Control 1 Intervention

Patients receiving preoperative mobility device(s) training before surgery

Group II: No Mobility Device Training Group Active Control 1 Intervention

Patients not receiving preoperative mobility device(s) training before surgery

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Participation in a preoperative online exercise and education program was linked to a shorter length of stay in the hospital after total joint arthroplasty, with a significant correlation (P=.037) observed in a study of 40 patients.

Improvement in exercise difficulty during the program was associated with decreased use of gait aids at 90 days post-surgery (P=.034), indicating that engaging in preoperative exercises may enhance recovery and independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Exercise Participation Reflects Patient Engagement and Predicts Earlier Patient Discharge and Less Gait Aid Dependence After Total Joint Arthroplasty. Denduluri, SK., Huddleston, JI., Amanatullah, DF.[2021]

A one-on-one preoperative physical therapy education session combined with a web-based microsite significantly improved patients' readiness to discharge from physical therapy after total joint arthroplasty, reducing the number of postoperative PT visits from an average of 4.4 to 3.3 visits.

Despite the improved readiness for discharge, there was no significant impact on the length of hospital stay or patient-reported functional outcomes (WOMAC scores) at 6 weeks, indicating that while preoperative education is beneficial, additional improvements in care are needed to reduce hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Physical Therapy Education Reduces Time to Meet Functional Milestones After Total Joint Arthroplasty. Soeters, R., White, PB., Murray-Weir, M., et al.[2020]

Patients who attended a preoperative education class before hip or knee arthroplasty showed significantly better physical therapy performance on postoperative Day 1, including greater ambulation distances and improved knee and hip flexion.

The study of 707 patients found that those who received preoperative education had a shorter hospital stay and a cost savings of approximately $921.57 per knee arthroplasty, highlighting the effectiveness of education in enhancing recovery and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Preoperative Education Prior to Hip or Knee Arthroplasty on Immediate Postoperative Outcomes. Jones, ED., Davidson, LJ., Cline, TW.[2022]

The Better in Better out™ (BiBo™) strategy aims to enhance patient outcomes by optimizing perioperative care through preoperative risk assessment, education, exercise therapy (prehabilitation), and postoperative mobilization, particularly for frail patients.

By improving preoperative physical fitness, patients are better equipped to handle major surgery, which can lead to fewer complications and improved recovery times after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improving pre- and perioperative hospital care : Major elective surgery]. Punt, IM., van der Most, R., Bongers, BC., et al.[2017]

Preoperative scapular rehabilitation significantly reduced pain and improved shoulder function in patients undergoing arthroscopic repair for rotator cuff injuries, with notable benefits observed after one year.

Patients who received scapular rehabilitation showed greater improvements in shoulder abduction and overall quality of life compared to those who did not, indicating that targeted preoperative exercises can enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. de Almeida, LL., Mendes Júnior, AF., Neto, JDM., et al.[2022]

The PROTEGO MAXIMA trial is evaluating an app-based endurance exercise program designed to improve physical fitness in patients before major surgery, with a focus on usability, validity, and safety using wearable technology to monitor heart rate and distance.

The study will assess the correlation between prehabilitation and postoperative complications, aiming to demonstrate that improved fitness through the app can lead to better surgical outcomes and reduced hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a pilot trial analysing the usability, validity and safety of an interventional health app programme for the structured prehabilitation of patients before major surgical interventions: the PROTEGO MAXIMA trial. Faqar-Uz-Zaman, SF., Sliwinski, S., Detemble, C., et al.[2023]

Early mobilization is essential in enhanced recovery after surgery (ERAS) pathways, as it significantly reduces postoperative complications and accelerates recovery, leading to shorter hospital stays and lower healthcare costs.

Barriers to early mobilization can be addressed through better education and resources, and recent innovations like wearable technology for real-time feedback can enhance compliance with mobilization recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early mobilization in enhanced recovery after surgery pathways: current evidence and recent advancements. Tazreean, R., Nelson, G., Twomey, R.[2022]

Preoperative strength training significantly improves early postoperative walking distances in patients undergoing total hip replacement (THR), highlighting the importance of physical activity before surgery.

Neither the type of anesthesia nor analgesia used during the procedure affected walking distances post-surgery, suggesting that preoperative exercise is a key factor in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative physical activity, anesthesia, and analgesia: effects on early postoperative walking after total hip replacement. Whitney, JA., Parkman, S.[2019]

A pilot study tested two prehabilitation apps aimed at helping patients reduce smoking and drinking before hip or knee surgery, with feedback indicating that while patients found the apps somewhat helpful, they did not lead to successful quitting.

Both apps received mixed reviews regarding usability and understanding, highlighting the need for significant improvements and additional support from addiction specialists to enhance their effectiveness in reducing preoperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two novel prehabilitation apps to help patients stop smoking and risky drinking prior to hip and knee arthroplasty. Tønnesen, H., Raffing, R., Lauridsen, SV., et al.[2023]

The clinical guideline provides evidence-based recommendations for implementing pre-operative exercise programs to enhance patient fitness before elective major surgery, addressing a gap in practical guidance.

Key areas covered include patient selection for exercise training, integration into multi-modal prehabilitation programs, and exercise prescription, emphasizing the need for these practices despite the call for further research on optimal exercise protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical guideline and recommendations on pre-operative exercise training in patients awaiting major non-cardiac surgery. Tew, GA., Ayyash, R., Durrand, J., et al.[2019]

Effective pre-operative planning involving surgeons, patients, and caregivers can significantly reduce the challenges faced by patients after foot and ankle surgery, particularly regarding mobility and daily activities.

Utilizing appropriate durable medical equipment and pre-operative gait training can enhance patient safety and mobility post-surgery, ensuring the operated area is protected while allowing for safe ambulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Convalescence. Richie, D., Bullard, D.[2019]

Educational interventions during the pre- and postoperative periods of hip arthroplasty significantly enhance functional capacity and quality of life for patients, as shown in a scoping review of 13 studies.

Early mobilization and rehabilitation exercises, promoted through education, are crucial for improving recovery outcomes, preventing complications, and facilitating quicker reintegration into daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Intervention in Rehabilitation to Improve Functional Capacity after Hip Arthroplasty: A Scoping Review. Nicolau, C., Mendes, L., Ciríaco, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative Exercise Participation Reflects Patient Engagement and Predicts Earlier Patient Discharge and Less Gait Aid Dependence After Total Joint Arthroplasty. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preoperative Physical Therapy Education Reduces Time to Meet Functional Milestones After Total Joint Arthroplasty. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Preoperative Education Prior to Hip or Knee Arthroplasty on Immediate Postoperative Outcomes. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Improving pre- and perioperative hospital care : Major elective surgery]. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for a pilot trial analysing the usability, validity and safety of an interventional health app programme for the structured prehabilitation of patients before major surgical interventions: the PROTEGO MAXIMA trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Early mobilization in enhanced recovery after surgery pathways: current evidence and recent advancements. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Preoperative physical activity, anesthesia, and analgesia: effects on early postoperative walking after total hip replacement. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Two novel prehabilitation apps to help patients stop smoking and risky drinking prior to hip and knee arthroplasty. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Clinical guideline and recommendations on pre-operative exercise training in patients awaiting major non-cardiac surgery. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Postoperative Convalescence. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Educational Intervention in Rehabilitation to Improve Functional Capacity after Hip Arthroplasty: A Scoping Review. [2022]