Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App for in-bed conditioning exercises, Usual care.
- Who it may be relevant to
- Registry conditions: Spine Degeneration, Hip Arthritis, Knee Osteoarthritis, Hip Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in patient performance during physical therapy (PT) [Time frame: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)]
Secondary outcome measures (7)
- Patient-reported satisfaction metrics [Time frame: at postoperative day 3-5]
- Length of stay [Time frame: an average of 3-5 days]
- Postoperative VAS scores [Time frame: immediately postoperative and day of last admission, up to 5 days]
- Patient performance on the app [Time frame: an average of 3-5 days]
- Patient compliance with prescribed exercises [Time frame: an average of 3-5 days]
- Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility [Time frame: up to 120 days]
- Adverse Events [Time frame: Up to 90 Days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Yale New Haven Hospital Saint Raphael's Campus — New Haven
Identifiers
NCT: NCT06407427 · 2000037597