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Clinical Trials/NCT06407427
NCT06407427
Recruiting
Not Applicable

Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients

Yale University1 site in 1 country100 target enrollmentJuly 21, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spine Degeneration
Sponsor
Yale University
Enrollment
100
Locations
1
Primary Endpoint
Change in patient performance during physical therapy (PT)
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2025
End Date
July 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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)

Patient performance during physical therapy will be assessed using The Activity Measure for Post-Acute Care (AMPAC). The AMPAC score is a comprehensive assessment tool used to evaluate a patient's functional abilities in various domains, including mobility, daily activities, and social interaction. Total score range from 6-24 with higher scores indicating the participant is able to independently perform all activities.

Secondary Outcomes

  • Patient-reported satisfaction metrics(at postoperative day 3-5)
  • Postoperative VAS scores(immediately postoperative and day of last admission, up to 5 days)
  • Patient performance on the app(an average of 3-5 days)
  • Patient compliance with prescribed exercises(an average of 3-5 days)
  • Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility(up to 120 days)
  • Length of stay(an average of 3-5 days)
  • Adverse Events(Up to 90 Days)

Study Sites (1)

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