Effect of Preoperative Mobility Device Training on Postoperative Fall Incidence

NCT ID: NCT03857945

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2026-05-31

Brief Summary

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.

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.

Conditions

Injury; Muscle, Ankle, and Foot, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mobility Device Training Group

Patients receiving preoperative mobility device(s) training before surgery

Group Type: ACTIVE_COMPARATOR

Preoperative mobility device(s) training

Intervention Type: OTHER

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 Mobility Device Training Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ashish Shah

Associate Professor, Foot & Ankle Division, Department of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashish B Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Hospital Highlands

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashish B Shah, MD

Role: CONTACT

ashishshah@uabmc.edu

(205) 930-6722

Aaradhana J Jha, MD

Role: CONTACT

aaradhana.jha@gmail.com

(617) 378 5116

Facility Contacts

Ashish Shah, MD

Role: primary

ashishshah@uabmc.edu

2059306722

Jessica McKnight

Role: backup

jdmcknight@uabmc.edu

2059306722

Other Identifiers

021-13307-E

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300002190-001

Identifier Type: -

Identifier Source: org_study_id