Clinical trial NCT04520854: Telehealth Delivered Physical Rehabilitation for an Ankle Sprain
Official title: Physical Rehabilitation Through Telehealth for an Ankle Sprain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Sprains
Telerehabilitation
Analgesic, Opioid
Analgesics, Non-narcotic
Anti-Inflammatory Agents, Non-Steroidal
Implementation Science
Acute Pain
Quality of Life
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Specific Aims will be addressed using a single-blind, parallel-am randomized control trial. The independent variables will be group (Telehealth, usual care) and time (baseline, post-intervention, 1-month follow-up). Participants assigned to the Telehealth group will complete a 2-week intervention consisting of 5 live-video sessions. A 2-week intervention will be used to allow for the normal recovery of acute symptoms and account for the average number of supervised physical rehabilitation visits (5 sessions) currently recommended. The usual care group will be instructed to follow their physicians' orders during the two-week intervention period. The dependent variables for will be assessed on the injured limb only for both groups. A Co-I will collect all dependent variables and will be blinded to group assignment.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 acute lateral ankle sprain (LAS) and not receiving a physical therapy referral from their treating physician will be enrolled. A LAS will be defined as an incident in which the rearfoot was inverted and resulted in a combination of pain, swelling and time lost from activity for at least one day.
* Participants with or without a prior history of an ankle sprain will be included unless 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 most recent injury occurred beyond six months prior to enrollment: 1) to ensure they recovered and returned to their normal activity; 2) to ensure they are experiencing acute rather than chronic symptoms; 3) to ensure they are all exposed to similar treatment options.All race and ethnic groups will be included.

Exclusion Criteria:

* Diagnosed with a concomitant injury (e.g., fracture)
* History of lower extremity surgery, or conditions other than an ankle sprain that affect balance and gait
* Do not speak English.

Primary outcomes:
measure: Change in Visual Analog Scale
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
measure: Change in Foot and Ankle Ability Measure (FAAM)
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
measure: Documentation of opioid and non-opioid medication consumed:
timeFrame: Total amount consumed between baseline to 24-72 hours immediately post intervention AND total amount consumed between immediately post intervention to 1 month folllow-up.
measure: Change in Feasibility of Intervention Measure (FIM):
timeFrame: Change from 24-72 hours immediately post intervention at 1 month follow-up.
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Post-intervention and 1-month follow-up
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Change from 24-72 hours immediately post intervention at 1 month follow-up.
measure: Disablement in the Physical Active Scale (DPA).
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
measure: International Physical Activity Questionnaire (IPAQ)- Short Form
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
measure: Weight-bearing lunge test (WBLT)
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
measure: Star-Excursion Balance Test (SEBT)
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
measure: Static Postural Control
timeFrame: Change from baseline at 24-72 hours immediately post intervention AND change from immediately post intervention at 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kyle Kosik, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: