Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06407427
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Yale University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rajiv S Vasudevan, M.D.
Principal Investigator Affiliation Yale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spine Degeneration, Hip Arthritis, Knee Osteoarthritis, Hip Fractures
Additional Details

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.

Arms & Interventions

Arms

Experimental: Enhanced Care

Post-operative usual care where patients will receive standard care plus the use of a tool.

Active Comparator: Usual Care

Post-operative usual care where patients will receive standard care alone.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale New Haven Hospital Saint Raphael's Campus

New Haven 4839366, Connecticut 4831725, 06510

Site Contact

Rajiv S Vasudevan, M.D.

[email protected]

650-714-7908