Clinical trial NCT06407427: Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation
Official title: Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spine Degeneration
Hip Arthritis
Knee Osteoarthritis
Hip Fractures
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

Detailed description: The study aims to assess the effectiveness of a mobile app-based tool in improving conditioning, mobility, and physical therapy performance among patients recovering from orthopedic surgery, particularly hip fracture fixation, spinal fusion, and total knee/hip arthroplasty. The app sets reminders for in-bed conditioning exercises, with difficulty levels adjusted based on patient feedback. The prospective, single-arm pilot study will enroll patients over 65 years old with adequate cognitive status and a mobile phone. Patient performance on the app, satisfaction metrics, and physical therapy outcomes will be evaluated, along with feedback from physical therapists. The study is conducted through the Yale New Haven Health System, with plans to enroll 15 patients initially and subsequently expand to a randomized controlled trial with 50 participants in each arm. The goal is to improve outcomes in this population, characterized by poor mobility, morbidity, and mortality rates, by supplementing inpatient rehabilitation with targeted, app-prompted exercises.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* English reading/speaking
* Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
* Must be able bodied enough to participate in a mobile app tool for physical therapy
* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Exclusion Criteria:

* Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
* Severe physical impairment:

  * Neurologic paralysis
  * Polytraumas with restrictions incompatible with anti-gravity exercises
  * Knee immobilization, bed rest
* Unstable medical conditions:

  * On ventilatory support
  * Utilizing high degrees of oxygen support (continuous BiPAP, high flow nasal cannula, nonrebreather mask, aerosol mask \>3L/min)
  * Hemodynamic instability requiring pressor medication support (can include those on pressors for elevated mean arterial pressure goals (MAPs))
  * Neurologically instable with strokes, hemorrhages, increased intracranial pressures
* Open wounds or surgical incisions

  * Tenuous closed wounds requiring immobilization or bending restrictions
  * Open wounds that are either packed/dressed or dressed with a wound vacuum
  * Surgical wounds that are draining fluid or purulence
* Vulnerable populations

  * Incarcerated individuals
* Patients without access to a mobile phone with iOS capability

Primary outcomes:
measure: Change in patient performance during physical therapy (PT)
timeFrame: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)
Secondary outcomes:
measure: Patient-reported satisfaction metrics
timeFrame: at postoperative day 3-5
measure: Length of stay
timeFrame: an average of 3-5 days
measure: Postoperative VAS scores
timeFrame: immediately postoperative and day of last admission, up to 5 days
measure: Patient performance on the app
timeFrame: an average of 3-5 days
measure: Patient compliance with prescribed exercises
timeFrame: an average of 3-5 days
measure: Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility
timeFrame: up to 120 days
measure: Adverse Events
timeFrame: Up to 90 Days
Other outcomes:
Locations:
Study officials:
References: