Mobile App for Ankle Sprain Recovery

(SPRAIN Trial)

Overseen By Naveen Poonai, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Naveen Poonai

Disqualifiers: Non-ambulatory, Developmental disability, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Ankle sprains are the most common musculoskeletal complaint of children presenting to the emergency department (ED). Healing can often be protracted, leading to prolonged pain, missed school and work, and delayed return to a normal activity level. Smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in a number of conditions but have not been explored in ankle sprains. We would like to know if using a smartphone app for children with ankle inversion injuries leads to improved functional outcomes such as pain, mobility, and return to activity. We will be comparing a smartphone app that provides education and daily management reminders to a paper handout to see if the former leads to improved functional recovery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Mobile App for Ankle Sprain Recovery treatment?

Research shows that mobile-based rehabilitation, which includes strength and balance training, can be effective for ankle sprain recovery, as seen in a study with adolescent football players. Both supervised and mobile-based rehabilitation improved muscle strength and balance over eight weeks, suggesting that a mobile app could be a helpful tool for recovery. ^{1 2 3 4 5}

Is the mobile app for ankle sprain recovery safe for humans?

The mobile-based rehabilitation app for ankle sprain recovery has been used safely by high school football players, showing improvements in strength and balance over an 8-week period, suggesting it is generally safe for human use. ^{2 5 6 7 8}

How is the Mobile App for Ankle Sprain Recovery different from other treatments for ankle sprains?

The Mobile App for Ankle Sprain Recovery is unique because it allows patients to perform rehabilitation exercises at home using a smartphone, providing guidance and feedback remotely. This is particularly beneficial for those who cannot access expert-supervised rehabilitation in person, making it a convenient alternative to traditional in-person therapy. ^{1 2 4 5 9}

Research Team

Janet Knechtel, BA

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

This trial is for children and young adults aged 12-30 who have recently (within the last 48 hours) injured their ankle. Participants must be seen at specific emergency departments in London, Ontario, and be able to use a smartphone with WiFi that can download the recovery app.

Inclusion Criteria

Presenting to the Paediatric Emergency Department of the Children's Hospital or Adult Emergency Department, London Health Sciences Centre, London, or Ontario, St. Joseph Urgent Care Centre, London, Ontario, with a unilateral acute (<= 48 hours) ankle injury based on clinical diagnosis by ED physician

I am between 12 and 30 years old.

Able to use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.

Exclusion Criteria

I have a confirmed fracture or dislocation in my leg, except for certain growth plate injuries.

I needed help to walk before my injury.

I have a developmental disability that affects my understanding of the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use a smartphone app or receive standard care instructions for managing ankle inversion injuries, including pharmacologic and non-pharmacologic approaches

2 weeks

Daily self-reporting via app or paper

Follow-up

Participants are monitored for functional recovery and pain management effectiveness

2 weeks

Self-reported outcomes on days 3, 5, 7, 10, 12, and 14

Treatment Details

Interventions

• Smartphone App
• Standard of Care

Trial Overview The study is testing if a mobile app can help improve recovery from acute ankle injuries compared to standard paper handouts. The app provides educational information and daily management reminders aimed at reducing pain, improving mobility, and speeding up return to normal activities.

Participant Groups

Group I: Smartphone App Experimental Treatment 1 Intervention

The mobile app will allow recording of study outcomes (pain using the vNRS and functional outcomes using the ASKp) and house an interactive educational component to provide daily reminders on pharmacological (ibuprofen and acetaminophen) and non-pharmacological (ice, elevation, and range of motion exercises) for pain management and when to return to activity. The app will collect pain scores using the verbal Numeric Rating Scale (vNRS) and functional outcomes using the Activities Scale for Kids (ASKp) scores on days 3, 5, 7, 10, 12, and 14. The ASKp will be completed by the child with assistance from the caregiver.

Group II: Standard of Care Active Control 1 Intervention

The standard of care group will be asked to read the paper-based discharge instructions in the ED, outlining pharmacological and non-pharmacological pain management and return to activity identical to the information contained in the mobile app. They will download onto their smartphone device a Data Collection App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, and pain using the vNRS and ASKp scores on days 3, 5, 7, 10, 12, and 14. The ASKp will be completed by the child with assistance from the caregiver.

Who Is Running the Clinical Trial?

Naveen Poonai

Lead Sponsor

Trials

3

Recruited

830+

Findings from Research

In a study of 245 patients with acute ankle sprains, 82.9% adhered to the prescribed rehabilitation program, indicating good compliance with treatment.

While there was no significant link between overall rehabilitation compliance and recovery, specific treatments like massage and proprioceptive training were associated with better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence and effectiveness of rehabilitation in acute ankle sprain. Guillodo, Y., Le Goff, A., Saraux, A.[2015]

Functional treatment options, such as elastic bandaging and taping, are statistically more effective than immobilization for managing mild-to-moderate ankle sprains, based on a review of 33 studies from the last decade.

For severe ankle sprains, a short period of immobilization using a cast or pneumatic brace leads to quicker recovery compared to just using a compression bandage, highlighting the importance of appropriate treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing ankle sprains in primary care: what is best practice? A systematic review of the last 10 years of evidence. Seah, R., Mani-Babu, S.[2018]

A prognostic model for predicting poor recovery after ankle sprain was developed using data from 584 participants and validated with an additional 682 participants, identifying key predictors such as age, BMI, and pain levels.

The updated model showed improved discrimination for predicting recovery outcomes (C-statistic of 0.78), making it a useful clinical tool for assessing recovery potential in patients with ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and prospective external validation of a tool to predict poor recovery at 9 months after acute ankle sprain in UK emergency departments: the SPRAINED prognostic model. Schlussel, MM., Keene, DJ., Collins, GS., et al.[2021]

A systematic review of 21 studies found that training programs are more effective than conservative treatments for improving pain and function in patients with chronic complaints after ankle sprains.

There is limited evidence suggesting that proprioceptive training can reduce the recurrence of ankle sprains, while the effectiveness of surgical treatments remains unclear due to a lack of comparative studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. van Ochten, JM., van Middelkoop, M., Meuffels, D., et al.[2022]

A study involving 60 high school football players with recurrent ankle sprains found that mobile-based rehabilitation (MBR) at home can effectively improve ankle strength and balance over 8 weeks, similar to expert-supervised rehabilitation (SVR).

While the SVR group showed early improvements in strength and balance by week 4, both groups demonstrated significant progress by week 8, suggesting that MBR is a viable alternative for athletes unable to attend in-person rehabilitation due to circumstances like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mobile-Based Rehabilitation in Adolescent Football Players with Recurrent Lateral Ankle Sprains during the COVID-19 Pandemic. Qu, X., Li, K., Nam, S.[2022]

In the first week after an acute ankle sprain, participants who followed a standard treatment were significantly less active than those who engaged in additional therapeutic exercises, suggesting that exercise can improve physical activity levels during recovery.

Both treatment groups (standard and exercise) showed reduced physical activity compared to a healthy control group, indicating that ankle sprains lead to decreased activity levels, which can be partially improved with structured exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional management of ankle sprains: what volume and intensity of walking is undertaken in the first week postinjury. Tully, MA., Bleakley, CM., O'Connor, SR., et al.[2022]

The 'Versterk je Enkel' App, designed to prevent ankle sprain recurrences, was well-received by users with high ratings for its relevance and usefulness, but it only reached 2.6% of the intended target population, indicating a significant gap in engagement.

Despite positive user feedback, compliance with the program within the App was low, highlighting the need for improved strategies to enhance uptake and usage among the target audience for effective injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an app-based neuromuscular training programme to prevent ankle sprains: a process evaluation using the RE-AIM Framework. Vriend, I., Coehoorn, I., Verhagen, E.[2022]

A systematic review of 31 studies on acute lateral ankle sprains found that while pain significantly decreased within the first 2 weeks, 5% to 33% of patients still experienced pain after 1 year, indicating that recovery can be prolonged.

The risk of re-sprains was notable, with 3% to 34% of patients experiencing at least one re-sprain within 2 weeks to 96 months post-injury, highlighting the importance of rehabilitation and preventive measures in managing ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the clinical course of acute ankle sprains? A systematic literature review. van Rijn, RM., van Os, AG., Bernsen, RM., et al.[2022]

A multidisciplinary rehabilitation approach using mobile health applications significantly improved recovery outcomes for patients with ankle fractures, including reduced swelling and pain, and enhanced mobility and quality of life.

The study highlights that while some residual deficits may remain, the use of mobile apps in conjunction with physiotherapy creates a strong foundation for further specialized rehabilitation techniques, promoting full recovery of lower limb function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of multidisciplinary rehabilitation therapy using mobile applications in cases of ankle fractures. Kasnakova, P., Mihaylova, A., Djurdjev, B., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Adherence and effectiveness of rehabilitation in acute ankle sprain. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Managing ankle sprains in primary care: what is best practice? A systematic review of the last 10 years of evidence. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Development and prospective external validation of a tool to predict poor recovery at 9 months after acute ankle sprain in UK emergency departments: the SPRAINED prognostic model. [2021]

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

Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Mobile-Based Rehabilitation in Adolescent Football Players with Recurrent Lateral Ankle Sprains during the COVID-19 Pandemic. [2022]

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

Functional management of ankle sprains: what volume and intensity of walking is undertaken in the first week postinjury. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of an app-based neuromuscular training programme to prevent ankle sprains: a process evaluation using the RE-AIM Framework. [2022]

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

What is the clinical course of acute ankle sprains? A systematic literature review. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of multidisciplinary rehabilitation therapy using mobile applications in cases of ankle fractures. [2022]