Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Working in conjunction with 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.
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
Masking not feasible for this study.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UAB Hospital Highlands
Birmingham, Alabama 35205
Contact:
Ashish Shah, MD
205-930-6722
ashishshah@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Ashish B Shah, MD
(205) 930-6722
ashishshah@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.