Telehealth Delivered Physical Rehabilitation for an Ankle Sprain

Last updated: July 9, 2024
Sponsor: Kyle Kosik
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Acute Pain

Sprains

Treatment

Usual Care

Telehealth Protocol

Clinical Study ID

NCT04520854
60997
#1920GGP02
  • Ages 15-35
  • All Genders

Study Summary

A vast majority (75-85%) of ankle sprain patients treated in emergency departments (ED) receive pain medication and are not referred for physical rehabilitation. Therefore, purpose of this study is to increase access to the standard of care for an ankle sprain by provide patients with physical rehabilitation delivered through telehealth. The purpose of this study includes compare a 2-week telehealth intervention to the usual care for treating 1) subjective function; 2) physical impairments; 3) medication consumption; and 4) patient-perceived barriers. The central hypothesis is participants receiving the 2-week telehealth intervention will 1) have less pain and disability; 2) improve balance and ankle range of motion; 3) consume less medication; and 4) reports positive feedback compared to the usual care group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All race and ethnic groups

  • Men and women between 15-35 years of age

  • Discharged from an ED within 72 hours of being diagnosed with a grade 1 or 2 acutelateral ankle sprain (LAS) and not receiving a physical therapy referral from theirtreating physician will be enrolled. A LAS will be defined as an incident in whichthe rearfoot was inverted and resulted in a combination of pain, swelling and timelost from activity for at least one day.

  • Participants with or without a prior history of an ankle sprain will be includedunless the most recent injury occurred within six months prior to enrollment.Participants with a prior history of ankle sprain will only be included if the mostrecent injury occurred beyond six months prior to enrollment: 1) to ensure theyrecovered and returned to their normal activity; 2) to ensure they are experiencingacute rather than chronic symptoms; 3) to ensure they are all exposed to similartreatment options.All race and ethnic groups will be included.

Exclusion

Exclusion Criteria:

  • Diagnosed with a concomitant injury (e.g., fracture)

  • History of lower extremity surgery, or conditions other than an ankle sprain thataffect balance and gait

  • Do not speak English.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
June 30, 2025

Study Description

Musculoskeletal injuries account for 15% of all emergency department (ED) visits in the United States. More than 1 million people are treated in the ED every year for an ankle sprain; making it the most common musculoskeletal injury. Most ankle sprain patients do not receive the recommended care because the vast majority (75-85%) are prescribed opioid or non-opioid medication and are not referred for follow-up health care services. Physical rehabilitation is the gold standard for follow-up care because of its known benefits as a non- pharmacological alternative to pain management and for restoring normal function. However, ankle sprain patients aren't referred to physical rehabilitation because of the lack of access to timely health care services, particularly for rural communities or underserved urban areas. A lack of access and/or increased wait time from referral to the first outpatient visit has been associated with detrimental physical and psychological effects. In fact, without physical therapy, ankle sprain patients can develop chronic pain, become less physically active, report having a worse health-related quality of life, suffer a recurrent injury and show early symptoms of post- traumatic osteoarthritis. Telehealth is a novel method of care delivery designed to bridge this gap by leveraging live-video communication platforms to provide timely health care services. Therefore, the rationale for this project is demonstrating the benefits of telehealth to deliver the standard of care for an ankle sprain will lead to new methods providing timely access to follow-up health care services for patients discharged from the ED for not only an ankle sprain, but a wide variety of musculoskeletal injuries. The specific aims for the proposed research include comparing a 2-week telehealth intervention to the usual care for 1) treating pain, disability, health-related quality of life, and physical activity; 2) ankle range of motion, static and dynamic balance; 3) opioid and non-opioid medication consumption; and 4) the feasibility, acceptability and appropriateness of each intervention. The investigators hypothesize, compared to the usual care, participants receiving telehealth will 1) have less pain and disability; 2) a better health-related quality; 3) increased physical activity levels; 4) greater ankle range of motion; 5) better static and dynamic balance; 5) take fewer opioid and non-opioid medication; and 5) report positive feedback. A single-blind, randomized control trial will assign 70 ankle sprain patients discharged from the ED to two equal groups (Telehealth, usual-care). The telehealth intervention includes 5-live video sessions with an investigator providing education about injury management, long-term health and therapeutic exercises. The usual care group will follow their physicians' orders. The expected outcomes will illustrate the value of immediate access to rehabilitative services delivered via telehealth for an ankle sprain.

Connect with a study center

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

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