Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

NCT06407427 | Recruiting

• 1 other identifier: 2000037597
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spine Degeneration; Hip Arthritis; Knee Osteoarthritis; Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Change in patient performance during physical therapy (PT)

  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.

  Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)

Secondary Outcomes (7)

• Patient-reported satisfaction metrics

  at postoperative day 3-5

• Length of stay

  an average of 3-5 days

• 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

Study Arms (2)

Enhanced Care

EXPERIMENTAL

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

Device: App for in-bed conditioning exercises; Other: Usual care

Usual Care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

App for in-bed conditioning exercises DEVICE

Participants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients

Enhanced Care

Usual care OTHER

All participants will receive usual care in the post-operative setting.

Enhanced Care; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital Saint Raphael's Campus

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Hip Fractures

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Rajiv S Vasudevan, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajiv S Vasudevan, M.D.

CONTACT

650-714-7908; Rajiv.vasudevan@yale.edu

David Gargano, PA-C

CONTACT

475-414-4317; david.gargano@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: July 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)