Effect of Preoperative Mobility Device Training on Postoperative Fall Incidence

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.

Study Overview

• Status: Recruiting
• Conditions: Injury; Muscle, Ankle, and Foot, Multiple
• Intervention / Treatment: Other: Preoperative mobility device(s) training

Detailed Description

Most of the surgeries involving the foot and ankle require non-weight bearing status post operatively. Patients use crutches, walker or knee scooters during that period to avoid weight bearing. However, using any mobility device(s) requires training to avoid falls. Most of the falls happen during early post-operative period after any surgery. The usage of assistive mobility device(s) increases the risk of falls. Some studies have shown physical therapy and training to decrease this risk of falls. Physical training for usage of assistive devices can be done either preoperatively or post operatively. When training is done postoperatively, it may increase the risk of fall due to pain, usage of narcotic drugs, especially in older patients due to lack of muscle power. To prevent these increased risks, the training can be done preoperatively. However, the role of preoperative training regarding usage of assistive devices has not been emphasized in the literature. Hence, the aim of our current study is to evaluate the difference between preoperative training and no training before surgery on the use of mobility device(s).

250 patients will be enrolled in the study. Each participant will be stratified by randomization into either Group 1 or Group 2. Patients in Group 1 will receive training on the mobility device(s) during their standard pre-operative care whereas patients in Group 2 will not receive this training. This training is not a component of routine, standard pre-operative care. Each group will include 125 patients.

Working in conjunction with University of Alabama at Birmingham (UAB) Foot and Ankle Division of the Orthopaedic department, volunteers meeting inclusion criteria will be identified in the outpatient clinic setting. After thorough discussion of risks and benefits, potential volunteers will be consented for participation in the study. The volunteer's demographic data will be obtained including gender, age, and race. The patient will then undergo the "pre-operative mobility device(s) training" during the pre-operative physical therapy visit, if they are randomized to Group 1. Patients in Group 2 will not receive this training. The preoperative training will not incur any additional cost to the patient. Patients in both groups will then undergo standard operative care. During routine 2-week and 6-week follow-up visits, they will be asked questions from a questionnaire that will assess the number and details of any fall(s) they may have experienced.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashish B Shah, MD; Phone Number: (205) 930-6722; Email: ashishshah@uabmc.edu
• Study Contact Backup: Name: Aaradhana J Jha, MD; Phone Number: (617) 378 5116; Email: aaradhana.jha@gmail.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • UAB Hospital Highlands
      • Contact: Jessica McKnight; Phone Number: 2059306722; Email: jdmcknight@uabmc.edu
      • Contact: Ashish Shah, MD; Phone Number: 2059306722; Email: ashishshah@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18 and older
• undergoing elective unilateral foot/ankle surgery
• requiring a period of post-operative non-weight-bearing or partial-weight-bearing period as advised by the operating surgeon.

Exclusion Criteria:

• less than 18 years of age
• wheelchair-bound patients
• patients with history of previous use of post-operative mobility device(s)
• patients with ankle fractures, patients with previously diagnosed condition(s) with cognitive, balance, mobility impairment
• patients undergoing bilateral surgery
• patients requiring follow ups longer than 6 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mobility Device Training Group; Patients receiving preoperative mobility device(s) training before surgery	Other: Preoperative mobility device(s) training; Patients in Group 1 (the intervention, that is the mobility device training group group) will receive training on the mobility device(s) with the physical therapy visit during their standard pre-operative care.
No Intervention: No Mobility Device Training Group; Patients not receiving preoperative mobility device(s) training before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls in the post-operative period after foot and ankle surgery	Number of falls in the post-operative period after foot and ankle surgery	two weeks before surgery to six weeks after surgery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ashish B Shah, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: preoperative mobility device training
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: IRB-300002190-001; 021-13307-E (Other Grant/Funding Number: American Orthopedic Foot and Ankle Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No