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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two weeks of physical rehabilitation delivered via telehealth can improve recovery from ankle sprains compared to usual care. Researchers believe telehealth rehab might reduce pain, improve ankle function, and decrease the need for pain medication. Participants will either receive five telehealth rehab sessions over two weeks or follow the usual care guidelines. Ideal candidates are individuals aged 15-35 who were recently diagnosed with a mild ankle sprain and did not receive a physical therapy referral.

As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance recovery methods for ankle sprains.

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 prior data suggests that this telehealth protocol is safe for ankle sprain rehabilitation?

Research has shown that telehealth rehabilitation, including virtual physical therapy, is generally safe for people. Studies have found that patients feel comfortable and experience few side effects during these sessions. Most people handle the treatment well, with few serious problems reported, indicating low risks.

The American Physical Therapy Association has developed guidelines for telerehabilitation to ensure the treatment's safety and effectiveness.

Overall, telehealth rehabilitation appears to be a safe option for treating ankle sprains. It enables people to receive necessary care without leaving home, which can be particularly beneficial for those with limited mobility or access to care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telehealth rehabilitation protocol for ankle sprains because it offers a novel approach to recovery by leveraging live-video sessions. Unlike traditional in-person physical therapy, this method allows patients to receive personalized care remotely, which can be more convenient and accessible, especially for those with mobility challenges or busy schedules. Additionally, the structured 2-week protocol provides frequent, consistent interactions with healthcare professionals, potentially enhancing recovery outcomes by ensuring patients adhere to their rehabilitation exercises more effectively. This telehealth approach could revolutionize the standard of care by making rehabilitation more adaptable and patient-friendly.

What evidence suggests that telehealth rehabilitation is effective for ankle sprains?

This trial will compare telehealth physical therapy with usual care for treating ankle sprains. Research has shown that telehealth physical therapy is as effective as in-person therapy for various muscle and joint issues, including ankle sprains. Patients have experienced long-term improvements through remote home-based rehab programs, which typically include guided exercises and tips on managing injuries and maintaining health. Studies suggest this treatment can reduce pain, improve balance, and increase ankle movement. Additionally, patients in telehealth programs often report needing less medication. Overall, telehealth rehab presents a promising option for those with ankle sprains. ^{1 3 4 5 6}

Who Is on the Research Team?

Kyle Kosik, Ph.D.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9597043/

Telehealth Physical Therapy for Sports Medicine ... Patient satisfaction survey results demonstrated that telehealth patients compared with in-person patients were less likely to recommend visits to others (75.0% ...

2. trial.medpath.com trial.medpath.com/clinical-trial/4f20d6b4162498d8/nct04520854-physical-rehabilitation-ankle-sprain-telehealth

Telehealth Delivered Physical Rehabilitation for an Ankle Sprain The telehealth intervention includes 5-live video sessions with an investigator providing education about injury management, long-term health and therapeutic ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04520854/telehealth-delivered-physical-rehabilitation-for-an-ankle-sprain

Telehealth Delivered Physical Rehabilitation for an Ankle ... The telehealth intervention includes 5-live video sessions with an investigator providing education about injury management, long-term health ...

4. rehab.jmir.org rehab.jmir.org/2021/3/e31247/

Digital Rehabilitation for Acute Ankle Sprains: Prospective ... This is the first study presenting a fully remote home-based rehabilitation program for acute ankle sprains, with patients achieving sustained long-term ...

5. withpower.com withpower.com/trial/phase-acute-pain-2021-d03a1?condition=&query=Analgesic+Non+Narcotic&overallStatus=Recruiting&hasNoPlacebo=false

Telehealth 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11140266/

Telerehabilitation in Physical Therapist Practice: A Clinical ... A clinical practice guideline on telerehabilitation was developed by an American Physical Therapy Association volunteer guideline development group.