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Preoperative Mobility Device Training for Reducing Postoperative Falls
N/A
Recruiting
Led By Ashish B Shah, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
undergoing elective unilateral foot/ankle surgery
age 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks before surgery to six weeks after surgery
Awards & highlights
Study Summary
This trial will test whether giving patients training on how to use a mobility device before their surgery will reduce the number of postoperative falls.
Who is the study for?
This trial is for adults over 18 who need elective foot or ankle surgery and will have to avoid putting weight on it afterward. It's not for those under 18, wheelchair users, people who've used mobility devices after surgery before, those having surgery on both feet/ankles at once, needing follow-ups beyond 6 weeks, with ankle fractures or pre-existing cognitive/balance/mobility issues.Check my eligibility
What is being tested?
The study tests if teaching patients how to use mobility aids before their foot or ankle surgery can help prevent falls after the operation when they can't put weight on their foot. Participants are trained in using these devices prior to their scheduled surgeries.See study design
What are the potential side effects?
Since this trial involves training in the use of mobility devices rather than medication, typical drug side effects aren't expected. However, there may be risks associated with learning new equipment such as muscle strain or minor accidents during training.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for foot or ankle surgery on one side.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two weeks before surgery to six weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks before surgery to six weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of falls in the post-operative period after foot and ankle surgery
Trial Design
2Treatment groups
Active Control
Group I: Mobility Device Training GroupActive Control1 Intervention
Patients receiving preoperative mobility device(s) training before surgery
Group II: No Mobility Device Training GroupActive Control1 Intervention
Patients not receiving preoperative mobility device(s) training before surgery
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,062 Total Patients Enrolled
Ashish B Shah, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for foot or ankle surgery on one side.I am 18 years old or older.I have an ankle fracture or a condition affecting my thinking, balance, or ability to move.My surgeon advised me not to put weight on my operated area for a while.I am having surgery on both sides of my body.I am under 18 years old.I use a wheelchair for mobility.You have used a mobility aid after a previous surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Mobility Device Training Group
- Group 2: No Mobility Device Training Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are more individuals being sought to participate in this research?
"Correct. Information available on clinicaltrials.gov suggests this medical trial is searching for participants, which was first posted in September 2019 and most recently updated October 2022. 250 individuals are needed to be recruited from one single location."
Answered by AI
How many individuals have been accepted into this research effort?
"Affirmative. Clinicaltrials.gov contains evidence that the trial, first advertised on September 9th 2019 and last amended on October 7th 2022, is searching for a total of 250 volunteers at one medical site."
Answered by AI
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