Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT03857945

Conditions

Injury; Muscle, Ankle, and Foot, Multiple

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Preoperative mobility device(s) training

Study Details

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.

Conditions

Injury; Muscle, Ankle, and Foot, Multiple

Study ID

NCT03857945

Start date

Sep 9, 2019

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Mobility Device Training Group

Patients receiving preoperative mobility device(s) training before surgery

no intervention: No Mobility Device Training Group

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

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.

Primary outcome measure

  • Number of falls in the post-operative period after foot and ankle surgery [ Time Frame: two weeks before surgery to six weeks after surgery ]

Central Contacts and Locations

Central contacts

Ashish B Shah, MD

(205) 930-6722ashishshah@uabmc.edu

Aaradhana J Jha, MD

(617) 378 5116aaradhana.jha@gmail.com

Locations

UAB Hospital Highlands

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Ashish Shah, MD

2059306722ashishshah@uabmc.edu

Jessica McKnight

2059306722jdmcknight@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • preoperative mobility device training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-29.