Telehealth Delivered Physical Rehabilitation for an Ankle Sprain

NCT ID: NCT04520854

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-06-30

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.

Conditions

Ankle Sprains; Telerehabilitation; Analgesic, Opioid; Analgesics, Non-narcotic; Anti-Inflammatory Agents, Non-Steroidal; Implementation Science; Acute Pain; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2-week Telehealth Protocol

Participants randomized to this arm will receive 5 live-video sessions. The first 2 live-video sessions will occur during the first week, last 20 minutes each and separated by 48-72 hours. The last 3 live-video sessions will occur during the second week, last 30-minutes each and separated by 24-48 hours.

Group Type: EXPERIMENTAL

Telehealth Protocol

Intervention Type: OTHER

The first live-video session will orient participants to the features of the software, discuss the checklist to minimize environmental distractions, gauge how participants are managing their symptoms (pain, swelling) and provide non-pharmacological alternatives to supplement their current treatment strategies.

The second live-video session will be used re-examine how the participant is managing their symptoms (pain, swelling) and re-emphasize non-pharmacological alternatives.

The remaining live-video sessions will be focused on giving participants home-based therapeutic exercises. The therapeutic exercises will target the four main areas important to ankle sprain recovery: 1) range of motion; 2) balance; 3) gait; and 4) strength. All of the therapeutic exercises are based on previously published criteria for the rehabilitation of an LAS. The progression will start with single-plane, non-weight bearing or low-force activities and will advance at the same rate.

2-week Usual Care

The usual care group will be used to reflect the current care provided to patients after discharged from the emergency department for an ankle sprain.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

The usual care group will be instructed to follow their treating physicians' orders. Participants will not receive instructions on how to self-manage symptoms nor a home-based exercise program.

Interventions

Telehealth Protocol

The first live-video session will orient participants to the features of the software, discuss the checklist to minimize environmental distractions, gauge how participants are managing their symptoms (pain, swelling) and provide non-pharmacological alternatives to supplement their current treatment strategies.

The second live-video session will be used re-examine how the participant is managing their symptoms (pain, swelling) and re-emphasize non-pharmacological alternatives.

The remaining live-video sessions will be focused on giving participants home-based therapeutic exercises. The therapeutic exercises will target the four main areas important to ankle sprain recovery: 1) range of motion; 2) balance; 3) gait; and 4) strength. All of the therapeutic exercises are based on previously published criteria for the rehabilitation of an LAS. The progression will start with single-plane, non-weight bearing or low-force activities and will advance at the same rate.

Intervention Type: OTHER

Usual Care

The usual care group will be instructed to follow their treating physicians' orders. Participants will not receive instructions on how to self-manage symptoms nor a home-based exercise program.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyle Kosik

OTHER

Sponsor Role: lead

Responsible Party

Kyle Kosik

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kyle Kosik, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

#1920GGP02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

60997

Identifier Type: -

Identifier Source: org_study_id