Ankle SprainsSPRAINNCT03564015
Smartphone App to Improve Functional Outcomes in Ankle Sprains
A study testing Smartphone app and Paper handout in people with Ankle Sprains, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Smartphone app and Paper handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-21 years (ii) Presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario, with a unilateral acute (<48 hours) ankle inversion injury.
- Use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.
- The diagnosis of an ankle inversion injury will be made on a clinical basis by the treating emergency physician after a fracture has been ruled out radiographically. We will include all grades of ankle injuries, including suspected Salter-Harris I of the distal tibia or fibula.
Who cannot join
- Children unable to read or understand English above at least a grade 8 literacy level
- Children who are not independently ambulatory (without the use of an assistive device)
- Children with a developmental disability precluding the full comprehension of study-related procedures,
- Children with multi-system or multi-limb injuries
- Children with a concomitant lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone App to Improve Functional Outcomes in Children With Acute Ankle Inversion Injuries: a Randomized Controlled 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. The investigators 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. The investigators 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.
Read the detailed description
Comprehensive discharge instructions are an integral part of care children discharged from the emergency department (ED). Unfortunately, providing consistent and thorough discharge instructions is highly limited by the workflow constraints of a busy ED. Currently, paper instructions are the standard for providing ED discharge information. Yet, there remains a great deal of variety in delivery of discharge instructions (1) and there is evidence that patients often do not fully comprehend (2, 3), recall (4), nor comply (5) with discharge instructions. Consequently, caregivers often commit errors related to knowledge and execution of ED discharge instructions (6). The use of a smartphone app following discharge from the ED offers a potential means to improve adherence to discharge instructions through consistent information, simplification of content, and reminders (2). Acute ankle sprains are one of the most common complaints presenting to primary care offices and EDs (7). In Canada and the United States, there are more than 2 million ED visits annually due to ankle trauma in children; 85% due to forced inversion (8). Adolescents and young adults have the highest incidence of ankle sprain (7.2 per 1,000 person-years). Although ankle sprains are often perceived as minor injuries, they can have a highly variable prognosis, with up to 64% of patients failing to achieve full recovery (9). Current guidelines are limited in determining prognostic factors associated with functional recovery (9). The resulting 'one-size fits all' approach (controlling acute inflammatory symptoms (9), using cryotherapy and anti-inflammatory medications, and early mobilization (7)) fails to consider the grade of injury, baseline level of functioning, and individual pain tolerance of the child. Educational guidance individualized to pain beyond the ED may improve functional outcomes. As of 2015, 82% of people age 18-49 years owned an app-enabled smartphone, and over half (58%) download health related smartphone apps (10). In adult medicine, many health-related smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in allergic rhinitis (10), post-operative monitoring (11), and musculoskeletal conditions (12). In children and adolescents, several studies have explored smartphone apps for asthma (13) and diabetes (14, 15). To date however, no smartphone apps have been developed for acute musculoskeletal injury management in children.
- Conditions
- Ankle Sprains
- Being tested
- Smartphone app, Paper handout
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone appOther
Apple or Android app to provide education to guide functional recovery and allow recording of pain, management, and functional outcome using the Activities Scale for Kids performance version (ASKp) at home
Paper handoutOther
Paper handout to guide functional recovery. Also includes a version of the smartphone app described above that only allows recording of pain, functional outcome, and management at home.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone app | Experimental | The smartphone group will not be given paper-based discharge instructions in the ED. They will download onto their smartphone device an Intervention App that will allow recording of the above mentioned study outcomes and contains an interactive educational component encompassing the identical information outlined in the paper handout. The app will provide educational guidance towards recovery using a feedback algorithm that will recommend on a daily basis, the use of ice, elevation, range of motion exercises, and/or analgesics based on the participant's report of their pain using the FPS-R. Receives: Other: Smartphone app |
| Paper handout | Active comparator | The paper handout 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. They will download onto their smartphone device a Recording App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, pain using the Faces Pain Scale - Revised (FPS-R), and ASKp scores on days 3, 5, 7, 10, 12, and 14. Receives: Other: Paper handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities Scale for Kids performance version (ASKp)
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Measured: Day 14 +/- 1 day post-discharge
Secondary outcomes (5)
Activities Scale for Kids performance version (ASKp)
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Measured: Day 3, 5, 7, 10, and 12 +/- 1 day post-discharge
Time to return to baseline ASKp score
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Measured: Days 1-14 post discharge
Pain using the Faces Pain Scale - Revised (FPS-R)
Self-report 6-item ordinal scale ranging from 0-5 with higher score indicating more pain
Measured: Days 1-14 post discharge
Use of non-pharmacological measures (ice, compression, other)
Frequency
Measured: Days 1-14 post discharge
Use of pharmacological analgesia (NSAIDs, acetaminophen)
Frequency
Measured: Days 1-14 post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Feb 2020
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Why it stopped: The intervention (guidance recovery app) was malfunctioning and not storing data for efficacy outcomes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, randomized, open-label, controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet Knechtel, BA, Study chair, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564015
- Sponsor's protocol ID
- 111817
- Acronym
- SPRAIN
- Status last verified
- Jan 2023
- First submitted
- 9 Apr 2018
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App to Improve Functional Outcomes in Children With Acute Ankle Inversion Injuries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03564015
- Acronym / sponsor ID
- SPRAIN / 111817
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The intervention (guidance recovery app) was malfunctioning and not storing data for efficacy outcomes.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators 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. The investigators 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.
Detailed description
Comprehensive discharge instructions are an integral part of care children discharged from the emergency department (ED). Unfortunately, providing consistent and thorough discharge instructions is highly limited by the workflow constraints of a busy ED. Currently, paper instructions are the standard for providing ED discharge information. Yet, there remains a great deal of variety in delivery of discharge instructions (1) and there is evidence that patients often do not fully comprehend (2, 3), recall (4), nor comply (5) with discharge instructions. Consequently, caregivers often commit errors related to knowledge and execution of ED discharge instructions (6). The use of a smartphone app following discharge from the ED offers a potential means to improve adherence to discharge instructions through consistent information, simplification of content, and reminders (2). Acute ankle sprains are one of the most common complaints presenting to primary care offices and EDs (7). In Canada and the United States, there are more than 2 million ED visits annually due to ankle trauma in children; 85% due to forced inversion (8). Adolescents and young adults have the highest incidence of ankle sprain (7.2 per 1,000 person-years). Although ankle sprains are often perceived as minor injuries, they can have a highly variable prognosis, with up to 64% of patients failing to achieve full recovery (9). Current guidelines are limited in determining prognostic factors associated with functional recovery (9). The resulting 'one-size fits all' approach (controlling acute inflammatory symptoms (9), using cryotherapy and anti-inflammatory medications, and early mobilization (7)) fails to consider the grade of injury, baseline level of functioning, and individual pain tolerance of the child. Educational guidance individualized to pain beyond the ED may improve functional outcomes. As of 2015, 82% of people age 18-49 years owned an app-enabled smartphone, and over half (58%) download health related smartphone apps (10). In adult medicine, many health-related smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in allergic rhinitis (10), post-operative monitoring (11), and musculoskeletal conditions (12). In children and adolescents, several studies have explored smartphone apps for asthma (13) and diabetes (14, 15). To date however, no smartphone apps have been developed for acute musculoskeletal injury management in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group, randomized, open-label, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Smartphone app | Experimental | Other: Smartphone appThe smartphone group will not be given paper-based discharge instructions in the ED. They will download onto their smartphone device an Intervention App that will allow recording of the above mentioned study outcomes and contains an interactive educational component encompassing the identical information outlined in the paper handout. The app will provide educational guidance towards recovery using a feedback algorithm that will recommend on a daily basis, the use of ice, elevation, range of motion exercises, and/or analgesics based on the participant's report of their pain using the FPS-R. |
| Paper handout | Active comparator | Other: Paper handoutThe paper handout 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. They will download onto their smartphone device a Recording App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, pain using the Faces Pain Scale - Revised (FPS-R), and ASKp scores on days 3, 5, 7, 10, 12, and 14. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 12-21 years (ii) Presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario, with a unilateral acute (<48 hours) ankle inversion injury.
- Use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.
- The diagnosis of an ankle inversion injury will be made on a clinical basis by the treating emergency physician after a fracture has been ruled out radiographically. We will include all grades of ankle injuries, including suspected Salter-Harris I of the distal tibia or fibula.
Key exclusion criteria (5 listed)
- Children unable to read or understand English above at least a grade 8 literacy level
- Children who are not independently ambulatory (without the use of an assistive device)
- Children with a developmental disability precluding the full comprehension of study-related procedures,
- Children with multi-system or multi-limb injuries
- Children with a concomitant lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone appApple or Android app to provide education to guide functional recovery and allow recording of pain, management, and functional outcome using the Activities Scale for Kids performance version (ASKp) at home | Other | Smartphone app |
| Paper handoutPaper handout to guide functional recovery. Also includes a version of the smartphone app described above that only allows recording of pain, functional outcome, and management at home. | Other | Paper handout |
Primary outcome
Activities Scale for Kids performance version (ASKp)
Time frame: Day 14 +/- 1 day post-discharge
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
5 secondary outcomes
Activities Scale for Kids performance version (ASKp)
Time frame: Day 3, 5, 7, 10, and 12 +/- 1 day post-discharge
Time to return to baseline ASKp score
Time frame: Days 1-14 post discharge
Pain using the Faces Pain Scale - Revised (FPS-R)
Time frame: Days 1-14 post discharge
Use of non-pharmacological measures (ice, compression, other)
Time frame: Days 1-14 post discharge
Use of pharmacological analgesia (NSAIDs, acetaminophen)
Time frame: Days 1-14 post discharge
Results and safety
The study was stopped early (reason given: The intervention (guidance recovery app) was malfunctioning and not storing data for efficacy outcomes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Knechtel, BA study chair
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone app and Paper handout in people with Ankle Sprains, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The intervention (guidance recovery app) was malfunctioning and not storing data for efficacy outcomes.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities Scale for Kids performance version (ASKp) (time frame: Day 14 +/- 1 day post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.