Telehealth Rehabilitation for Ankle Sprains

Overseen By Joneen Lowman, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Kyle Kosik

Disqualifiers: Concomitant injury, Lower extremity surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it aims to reduce medication use through telehealth rehabilitation. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Telehealth Delivered Physical Rehabilitation for ankle sprains?

Research shows that telehealth physical therapy is as effective as in-person therapy for various musculoskeletal issues, providing high-quality care and patient satisfaction. This suggests that telehealth rehabilitation could be a promising option for treating ankle sprains. ^{1 2 3 4 5}

Is telehealth rehabilitation generally safe for humans?

Research shows that telehealth rehabilitation, including virtual physical therapy, is generally safe for humans. Studies have reported high levels of comfort and confidence among clients and therapists, although some barriers like ensuring patient safety without a caregiver present have been noted. ^{1 2 6 7 8}

How is Telehealth Delivered Physical Rehabilitation unique for treating ankle sprains?

Telehealth Delivered Physical Rehabilitation is unique because it allows patients to receive physical therapy remotely through real-time videoconferencing, making it accessible for those in remote areas or with mobility issues. This approach offers convenience and continuity of care without the need for in-person visits, which can be particularly beneficial for managing conditions like ankle sprains. ^{1 5 9 10 11}

Research Team

Kyle Kosik, Ph.D.

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for men and women aged 15-35 who've been diagnosed with a mild to moderate acute lateral ankle sprain in the last 72 hours, haven't had recent lower extremity surgery or injuries affecting balance and gait, speak English, and have not received physical therapy referrals.

Inclusion Criteria

I was diagnosed with a mild to moderate ankle sprain and left the emergency department without a referral for physical therapy.

You can join the study if you haven't injured your ankle in the last six months. But if you have, you can still join if it happened more than six months ago and you've fully recovered. This helps make sure everyone in the study has similar experiences with ankle injuries.

All race and ethnic groups

Exclusion Criteria

I have had surgery or conditions affecting my walking and balance, not including an ankle sprain.

I have been diagnosed with another injury, like a fracture.

I do not speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 2-week telehealth intervention with 5 live-video sessions for physical rehabilitation

2 weeks

5 visits (virtual)

Follow-up

Participants are monitored for changes in balance, medication consumption, and other outcomes post-intervention

4 weeks

Weekly phone interviews

Treatment Details

Interventions

• Telehealth Delivered Physical Rehabilitation

Trial Overview The study compares usual care with a new telehealth protocol over two weeks. It aims to see if the telehealth approach improves function, reduces pain and medication use, enhances balance and range of motion, while also assessing patient-perceived barriers.

Participant Groups

Group I: 2-week Telehealth Protocol Experimental Treatment 1 Intervention

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 II: 2-week Usual Care Active Control 1 Intervention

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.

Telehealth Delivered Physical Rehabilitation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Telehealth Physical Therapy for:

• Ankle sprains
• Musculoskeletal injuries
• Orthopedic conditions

Approved in European Union as Telemedicine Physical Rehabilitation for:

• Ankle sprains
• Musculoskeletal injuries
• Orthopedic conditions

Approved in Canada as Virtual Physical Therapy for:

• Ankle sprains
• Musculoskeletal injuries
• Orthopedic conditions

Who Is Running the Clinical Trial?

Kyle Kosik

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

A systematic review of 100 studies on telehealth in physical therapy revealed that most research focuses on musculoskeletal conditions, with Australia, Canada, and the US leading in published evidence.

Despite the growth in telehealth research, only 14% of studies utilized secure videoconferencing platforms, highlighting a gap in safety measures for delivering physical therapy services remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of real-time videoconferencing to deliver physical therapy services: A scoping review of published and emerging evidence. Horsley, S., Schock, G., Grona, SL., et al.[2021]

A study involving 66 individuals with chronic Achilles tendinopathy found that telehealth and hybrid formats of physical therapy were as effective as in-person therapy in reducing movement-evoked pain after 8 weeks.

All groups showed significant pain reduction, and the telehealth and hybrid groups did not exceed the noninferiority margin compared to in-person therapy, suggesting that telehealth can provide effective rehabilitation while enhancing accessibility and patient preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Telehealth for Movement-Evoked Pain in People With Chronic Achilles Tendinopathy: A Noninferiority Analysis. Post, AA., Rio, EK., Sluka, KA., et al.[2023]

Telehealth visits provide high-quality care with strong patient and provider satisfaction, showing that virtual physical therapy is just as effective as traditional in-person therapy for musculoskeletal disorders.

Postoperative telerehabilitation significantly improves clinical outcomes and offers increased intensity in rehabilitation programs, making it a promising option for patient recovery, especially following the COVID-19 pandemic which has enhanced telehealth reimbursement and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine for Musculoskeletal Rehabilitation and Orthopedic Postoperative Rehabilitation. Phuphanich, ME., Sinha, KR., Truong, M., et al.[2021]

Telehealth sessions that include physical therapists have been successfully used for various health services, such as physical examinations and shared appointments for diabetes management.

These sessions also support obesity and weight management classes, indicating that telehealth can effectively facilitate important health interventions remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Physical Therapist's Role in Clinical Video Telehealth. Gitlin-Nitti, YJ., Shah, CD., Kharlamb, V.[2023]

Telerehabilitation, particularly virtual physical therapy (PT), has shown to improve patient function and satisfaction, indicating its effectiveness as a healthcare delivery method.

The article emphasizes that ongoing research and technological advancements will enhance virtual PT, suggesting a promising future for its application across various treatment areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Physical Therapy and Telerehabilitation. Havran, MA., Bidelspach, DE.[2021]

Over 21 months, low-bandwidth videoconferencing successfully facilitated 47 physical rehabilitation consultations across various issues, demonstrating the feasibility of telemedicine in community hospitals.

More than 80% of clinicians supported the telemedicine approach, and all clients reported comfort and confidence in the teleconsultations, indicating high satisfaction with this remote service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-bandwidth, Internet-based videoconferencing for physical rehabilitation consultations. Lemaire, ED., Boudrias, Y., Greene, G.[2022]

A survey of 73 pediatric physical therapists revealed that most found telehealth easy to use and effective for delivering treatment, indicating its potential as a viable method for pediatric care.

The study identified three key themes for successful telehealth delivery: caregiver involvement, a well-equipped therapist toolbox for treatment and collaboration, and understanding the characteristics of the child client, which can help improve telehealth practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 Lessons From The Field: Toward A Pediatric Physical Therapy Telehealth Framework. Fishman, GD., Elkins, J.[2022]

Over 80% of physical therapists believe that telehealth is an effective platform for treating vestibular disorders, with 68% agreeing that patients achieve similar health outcomes compared to in-clinic care.

Despite some barriers, such as concerns about patient safety and challenges in conducting thorough vestibular exams, more than 75% of therapists felt comfortable treating common vestibular diagnoses via telehealth, indicating its potential as a viable rehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Rehabilitation Telehealth During the SAEA-CoV-2 (COVID-19) Pandemic. Harrell, RG., Schubert, MC., Oxborough, S., et al.[2022]

Telerehabilitation using videoconferencing has successfully provided specialist consultations to individuals in remote areas, with 117 encounters leading to changes in patient care plans.

Clinicians rated the effectiveness of these teleconsultations as good or excellent, demonstrating that telehealth can effectively support the care of patients with neurologic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation consultations for clients with neurologic diagnoses: cases from rural Minnesota and American Samoa. Savard, L., Borstad, A., Tkachuck, J., et al.[2019]

The COVID-19 pandemic has accelerated the shift to telehealth services, which are expected to remain popular due to their convenience and efficiency for both patients and surgeons.

A comprehensive virtual examination for foot and ankle conditions can be effectively conducted through telehealth, with minimal modifications needed for routine physical examination maneuvers when patients are properly instructed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Virtual Foot and Ankle Physical Examination. Eble, SK., Hansen, OB., Ellis, SJ., et al.[2020]

This protocol aims to evaluate the effectiveness of telerehabilitation in physical therapy for various conditions and populations, highlighting its potential to improve accessibility and continuity of care, especially during the COVID-19 pandemic.

The review will assess multiple outcomes, including clinical effectiveness, functionality, quality of life, satisfaction, adherence, and safety, ensuring a comprehensive understanding of telerehabilitation's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of telerehabilitation in physical therapy: A protocol for an overview in a time when rapid responses are needed. Serón, P., Oliveros, MJ., Fuentes-Aspe, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of real-time videoconferencing to deliver physical therapy services: A scoping review of published and emerging evidence. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Telehealth for Movement-Evoked Pain in People With Chronic Achilles Tendinopathy: A Noninferiority Analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Telemedicine for Musculoskeletal Rehabilitation and Orthopedic Postoperative Rehabilitation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Physical Therapist's Role in Clinical Video Telehealth. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Virtual Physical Therapy and Telerehabilitation. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Low-bandwidth, Internet-based videoconferencing for physical rehabilitation consultations. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

COVID-19 Lessons From The Field: Toward A Pediatric Physical Therapy Telehealth Framework. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Vestibular Rehabilitation Telehealth During the SAEA-CoV-2 (COVID-19) Pandemic. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Telerehabilitation consultations for clients with neurologic diagnoses: cases from rural Minnesota and American Samoa. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Virtual Foot and Ankle Physical Examination. [2020]

11. Chile pubmed.ncbi.nlm.nih.gov

Effectiveness of telerehabilitation in physical therapy: A protocol for an overview in a time when rapid responses are needed. [2022]