UAB Hospital Highlands
Birmingham, Alabama, 35205, United States
Location status: Recruiting
Location contact
Ashish Shah, MD
CONTACT
Jessica McKnight
CONTACT
NCT Number: NCT03857945
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35205, United States
Location status: Recruiting
Ashish Shah, MD
CONTACT
Jessica McKnight
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: two weeks before surgery to six weeks after surgery
Number of falls in the post-operative period after foot and ankle surgery
Contact information is provided by the study sponsor or research team.
Aaradhana J Jha, MD
CONTACT
Ashish B Shah, MD
CONTACT
University of Alabama at Birmingham
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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