Evaluation of Home-based Telerehabilitation Platform to Augment Orthopedic Rehabilitation

NCT06973642 | Recruiting

• 2 other identifiers: UMMC-IRB-2024-1786 U66RH31459-06-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

telerehabilitation; telehealth; physical therapy; Anterior Cruciate Ligament Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Time to initial physical therapy visit

  Number of days from the time the patient is enrolled in the study until the time they have their first physical therapy visit

  At study completion, average 1 year

• Time to first physical therapy visit scheduled

  Number of days from when the patient is enrolled to when their first physical therapy visit is scheduled

  At study completion, average 1 year

• Number of major adverse events reported from telehealth physical therapy services

  Numerical count of how many major adverse events patients or providers report

  Through study completion, an average of 1 year

• Number of Scheduled physical therapy visits completed by enrolled patients

  Number of scheduled physical therapy sessions completed by patients compared to number of sessions scheduled

  At study completion, average 1 year

• Number of participants' surveys that report satisfaction with telehealth services

  Participants will complete surveys after each telehealth session. Number of participants' surveys that report satisfaction compared to dissatisfaction will be measured.

  At study completion, average 1 year

• Number of providers' surveys that report satisfaction with telehealth application use

  Providers will complete surveys after each telehealth session. Number of providers' surveys that report satisfaction compared to dissatisfaction will be measured.

  At study completion, average 1 year

Secondary Outcomes (2)

• Lower Extremity Functional Scale

  Through study completion, an average of 1 year

• Operative lower extremity pain

  Through study completion, an average of 1 year

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

Patient participants will receive telehealth rehabilitation services Provider participants will be providing the physical therapy services.

Device: Software as a Medical Device (WizeCare)

Interventions

Software as a Medical Device (WizeCare) DEVICE

Telehealth services will be provided through a telerehabilitation platform with AI capabilities and markerless motion capture.

Telerehabilitation

Eligibility Criteria

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

You may qualify if:

• Patients that are candidates for anterior cruciate ligament reconstruction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

The University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Central Study Contacts

Jacob Daniels, DPT, EdD

CONTACT

6018154038; jbdaniels@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Feasibility Criteria 1. ≥80% of participants will have initial physical therapy visit scheduled within 1 week of enrollment 2. ≥80% of participants will complete their first physical therapy appointment within 1 week of surgery 3. Zero major adverse events will result from telehealth physical therapy services 4. Patient's will complete ≥70% of scheduled physical therapy visits 5. ≥70% of participants will report satisfaction with telehealth services 6. \>90% of providers will report satisfaction with use of the application to provide rehabilitation services

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-04

Locations

US (1)