Evaluation of Home-based Telerehabilitation Platform to Augment Orthopedic Rehabilitation

NCT06973642 — Not applicable, Recruiting, 15 participants, University of Mississippi Medical Center

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RegistryNCT06973642
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment15 (Estimated)
SponsorUniversity of Mississippi Medical Center (Other)
ConditionsAnterior Cruciate Ligament Reconstruction Rehabilitation
InterventionsSoftware as a Medical Device (WizeCare) (Device)
Datesstart 2025-06-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-05-15, last updated 2025-07-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Anterior Cruciate Ligament Reconstruction Rehabilitation All trials of Software as a Medical Device (WizeCare)

-Summary

The goal of this study is to assess the feasibility of utilizing a telehealth rehabilitation platform to increase patient access for individuals who have undergone orthopedic surgery.

Patient participants will be seen via telehealth until they are able to be seen by an in-person physical therapist of their choice.

Provider participants will be the physical therapist who are providing physical therapy services through the telehealth application.

Data collection:

Patient and provider post surveys Home program and scheduled visit compliance rate Healthcare information in keeping with Stand of care physical therapy practices

Feasibility criteria will be assessed to determine whether this modality improves physical therapy access for patients living in rural areas.

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+Arms and interventions

ArmTypeInterventionsDescription
TelerehabilitationExperimentalDevice: Software as a Medical Device (WizeCare)Patient participants will receive telehealth rehabilitation services Provider participants will be providing the physical therapy services.
  • Software as a Medical Device (WizeCare) (Device): Telehealth services will be provided through a telerehabilitation platform with AI capabilities and markerless motion capture.

+Outcome measures

Primary outcomes

  • Time to initial physical therapy visit [At study completion, average 1 year]: Number of days from the time the patient is enrolled in the study until the time they have their first physical therapy visit
  • Time to first physical therapy visit scheduled [At study completion, average 1 year]: Number of days from when the patient is enrolled to when their first physical therapy visit is scheduled
  • Number of major adverse events reported from telehealth physical therapy services [Through study completion, an average of 1 year]: Numerical count of how many major adverse events patients or providers report
  • Number of Scheduled physical therapy visits completed by enrolled patients [At study completion, average 1 year]: Number of scheduled physical therapy sessions completed by patients compared to number of sessions scheduled
  • Number of participants' surveys that report satisfaction with telehealth services [At study completion, average 1 year]: Participants will complete surveys after each telehealth session. Number of participants' surveys that report satisfaction compared to dissatisfaction will be measured.
  • Number of providers' surveys that report satisfaction with telehealth application use [At study completion, average 1 year]: Providers will complete surveys after each telehealth session. Number of providers' surveys that report satisfaction compared to dissatisfaction will be measured.

Secondary outcomes

  • Lower Extremity Functional Scale [Through study completion, an average of 1 year]: Lower Extremity Functional scale is a questionniare designed to assess functional status in patients with Lower extremity problems. The scale is 0-80 with a higher score demonstrating higher functional status
  • Operative lower extremity pain [Through study completion, an average of 1 year]: Pain in relation to the lower extremity that has undergone ACL reconstructive surgery will be measured on a 0-10 scale with 0 being no pain and 10 being worse pain.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients that are candidates for anterior cruciate ligament reconstruction.

Exclusion Criteria:

* Visual impairment greater than 20/200 with the use of corrective lenses
* Does not own or have consistent access to a phone with data capabilities
* Has been informed by their healthcare provider that they should not participate in physical therapy services
* Participants can be excluded from the study at any time if the physical therapist determines the patient is not an appropriate candidate for telehealth therapy.

+Locations (1)

FacilityCityCountryStatus
The University of Mississippi Medical CenterJackson, MississippiUnited StatesRecruiting