Injury; Muscle, Ankle, and Foot, MultipleNCT03857945
Effect of Preoperative Mobility Device Training on Postoperative Fall Incidence
A study testing Preoperative mobility device(s) training in people with Injury; Muscle, Ankle, and Foot, Multiple, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury; Muscle, Ankle, and Foot, Multiple
- What is being tested?
- Preoperative mobility device(s) training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Hospital Highlands
Birmingham, Alabama, 35205
Ashish Shah, MD, 2059306722, ashishshah@uabmc.edu
Jessica McKnight, 2059306722, jdmcknight@uabmc.edu
About this study
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.
Read the 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.
- Being tested
- Preoperative mobility device(s) training
- Keywords
- preoperative mobility device training
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative mobility device(s) trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobility Device Training Group | Active comparator | Patients receiving preoperative mobility device(s) training before surgery Receives: Other: Preoperative mobility device(s) training |
| No Mobility Device Training Group | No intervention | Patients not receiving preoperative mobility device(s) training before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two weeks before surgery to six weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start9 Sep 2019
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury; Muscle, Ankle, and Foot, MultipleStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashish Shah, University of Alabama at Birmingham
- Investigators
- Ashish B Shah, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857945
- Sponsor's protocol ID
- IRB-300002190-001
- Other IDs
- 021-13307-E
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Mobility Device Training on Postoperative Fall Incidence
- ClinicalTrials.gov ID
- NCT03857945
- Acronym / sponsor ID
- IRB-300002190-001
- Keywords
- preoperative mobility device training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mobility Device Training Group | Active comparator | Other: Preoperative mobility device(s) trainingPatients receiving preoperative mobility device(s) training before surgery |
| No Mobility Device Training Group | No intervention | –Patients not receiving preoperative mobility device(s) training before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative mobility device(s) trainingPatients 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. | Other | Mobility Device Training Group |
Primary outcome
Number of falls in the post-operative period after foot and ankle surgery
Time frame: two weeks before surgery to six weeks after surgery
Number of falls in the post-operative period after foot and ankle surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashish B Shah, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative mobility device(s) training in people with Injury; Muscle, Ankle, and Foot, Multiple, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashish B Shah, MD ((205) 930-6722, ashishshah@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.