An observational study in Gait, Unsteady, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Chicago · Observational
This is a prospective observational study looking at gait-cadence in older adults who are scheduled to have major abdominal surgery at the University of Chicago. The objective of the study is to evaluate whether gait-cadence, as measured from a patient's mobile device at-home, can provide an accurate assessment of a patient's functional status prior to major abdominal surgery and identify patients at risk of poor functional outcomes.
Over 100,000 older adults undergo elective major abdominal surgeries in the US each year and many experience loss of mobility after surgery that requires post-acute care. Risk of mobility loss is greater for older adults unable to engage in moderate-intensity physical activity before surgery. Additionally, recovery trajectories to baseline mobility remains poorly understood for older adults and may impact readmission. Functional status assessment before surgery can identify interventions to help older adults improve walking capacity and improve recovery trajectories after surgery. However, almost no patients receive objective functional status tests before surgery due to logistical and practical barriers. Remote assessments performed independently by the patient using wearable technology, such as smartphones, may provide a solution. Smartphone accelerometers combined with open-source software can directly measure a patient's gait-cadence, or the number of steps taken per minute. This observational cohort of older adults undergoing major abdominal surgery will use a novel smartphone application to obtain remotely collected gait-cadence from usual and fast paced walks prior to their in-clinic visit. Investigators will then compare the at-home to the in-clinic usual and fast paced walks and measure their recovery trajectory after surgery through weekly at-home walks. Overall mobility will be assessed using ActiGraph accelerometers worn for a 7-day time period before and after surgery. The investigator's hypothesis is that gait-cadence measured during usual and fast pace walks at-home will 1) provide an accurate and easy to use functional assessment 2) identify patients at-risk of mobility loss and 3) determine walking recovery trajectories for older adults after surgery. Results from this study will provide important knowledge on mobility trajectories of older adults after major abdominal surgery and develop a novel approach to identify high-risk older adults. Further, this platform may be leveraged to deliver mobility interventions before surgery to improve patient outcomes after surgery.
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's planned enrollment of 100 is above the median of 54 across 75 observational studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are 60 years or older who have surgery scheduled at University of Chicago that can walk independently with or without an assistive device.
Exclusion Criteria:
Patients who are scheduled to have surgery at University of Chicago Medical Center (UCMC) who agree to use the step test application and study accelerometer before and after their surgery.
Accuracy of gait-cadence measured from at-home and in-clinic walk tests as measured by ActivPAL accelerometers.
ActivPAL accelerometer will be worn during in-clinic walk tests to serve as reference of steps walked during the at-home walk tests.
Time frame: Baseline (Before surgery)
Change in disability, as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0: 12-item.
The simple sum of the scores of the 12-items range from 0 to 48 with higher scores indicating greater disability.
Time frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Change in functional status, as measured by an interview in which participants will be asked, "At the present time, do you need help from another person to (complete the task)?"
Interview question will be asked for 13 different tasks. An increased need for personal assistance demonstrates greater functional status decline.
Time frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Change in global health, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health.
Total raw scores are between 4 and 20, and these can be converted to a T-score. Higher scores mean more of the concept being measured. For example, higher scores mean more health.
Time frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Change in pain interference, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 6a.
Total raw score ranges from 6 to 30, and these can be converted to a T-score. Higher scores indicate greater pain interference on relevant aspects of a participant's life.
Time frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Change in gait-cadence after surgery
Gait-cadence will be measured at-home after surgery from weekly at-home walking tests from smartphone
Time frame: Weeks 1-8 after surgical procedure
Plan to share: No
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