Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enhanced Care
Post-operative usual care where patients will receive standard care plus the use of a tool.
  • Device: App for in-bed conditioning exercises
    Participants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients
  • Other: Usual care
    All participants will receive usual care in the post-operative setting.
Active Comparator
Usual Care
Post-operative usual care where patients will receive standard care alone.
  • Other: Usual care
    All participants will receive usual care in the post-operative setting.

Recruiting Locations

Yale New Haven Hospital Saint Raphael's Campus
New Haven, Connecticut 06510
Contact:
Rajiv S Vasudevan, M.D.
650-714-7908
Rajiv.vasudevan@yale.edu

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Rajiv S Vasudevan, M.D.
650-714-7908
Rajiv.vasudevan@yale.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.