Effectiveness of a Telerehabilitation Program in Ankle Sprain
Condition: Ankle Sprain; Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      Ankle sprain is the most common sprain. Their care entails a high cost due to the incapacity
      for work that it generates. An early and timely intervention for the treatment of ankle
      sprain reduces the days of disability and functional recovery is faster. Strategies must be
      generated to provide timely care in rehabilitation. Telerehabilitation is a viable option to
      partially solve this problem. The purpose of this study is evaluate the effectiveness of
      functional ankle recovery after a telerehabilitation program in patients with sprain in the
      first level of care. Material and method: Controlled clinical trial, 92 subjects with grade 1
      and 2 ankle sprain will be included; they will be divided into two groups, with randomized
      allocation. One group will receive usual care (n = 41) for ankle sprain and another will
      receive regular care plus telerehabilitation (n = 41) through a digital platform course, it
      will consist of video and written instructions. Foot and Ankle Ability Measure (FAAM) will be
      measured at baseline and weekly, until completing 4 weeks. Group experience: The group is
      trained for the development of the contents and the rehabilitation program, with clinical
      experience in evaluation, treatment and rehabilitation of ankle sprain.
    

Detailed description: 
      Ankle sprain (AS) is a soft tissue injury caused by a forced twisting movement that exceeds
      the normal limits of the joint. This injury can range from minimal tissue distention to
      complete tissue rupture, it is manifested clinically by pain, edema, and functional
      limitation of the joint.

      AS is the injury most related to physically active people, the worldwide incidence is
      estimated at 1 in every 10,000 people, it represents 15 to 20% of all sports injuries and
      most frequently affects young adults, its frequency has led it to be considered a benign
      condition, however, 20% of cases will develop complications.

      After presenting a AS, the effects on health and costs of care are frequently underestimated
      by health personnel and the patient. The economic costs of your care are highly variable,
      they depend on the severity of the injury and the therapeutic strategy used; in most cases,
      it takes several days of disability for the injured limb to recover, causing absenteeism from
      work. Likewise, the frequency and variability with which the treatment of is selected can
      affect the recovery time and the quality of life of the patient.

      The most important component of treatment for AS is rehabilitation, since it accelerates
      healing and return to desired activities, however, a large number of patients do not receive
      this therapeutic component adequately. Currently there are changes in the way of care for
      patients, largely due to the health contingency caused by Coronavirus disease 2019
      (COVID-19), where social distance is a recommended action, for this reason, telemedicine is a
      strategy that can help the care of patients with conditions that require rehabilitation;
      therefore, some countries included digital practice within their health system.

      When introducing a new therapeutic strategy, the economic and health effects, positive and
      negative, must be taken into account; cost-effectiveness studies are useful to know these
      effects. There are few cost-effectiveness studies for AS where telerehabilitation is compared
      with usual treatments at the first level of care. The evidence on measures of the
      effectiveness of Interventions through the telerehabilitation of AS is limited. The results
      also suggest that, in low- and middle-income countries, these pieces of evidence are even
      more limited. Some studies have shown that a distance intervention in orthopedic
      consultations is equal to or more cost-effective than standard consultations, where patients
      must attend a face-to-face consultation with the doctor.

      What is known is that early rehabilitation as an optimized treatment for ankle sprain reduces
      treatment costs and reduces complications. However, the effectiveness of a telerehabilitation
      intervention for AS like the one proposed in this protocol is still unknown.

      The research question is: what is the effectiveness in functional ankle recovery after a
      tele-rehabilitation program in patients with sprain in the first level of care, in a
      controlled and cost-effective clinical trial?

      Our objective is: to evaluate the effectiveness in functional recovery of the ankle after a
      telerehabilitation program in patients with sprain grade 1-2 in the first level of care, in a
      controlled and cost-effectiveness clinical trial.

      The investigators hypothesize: there will be the same or greater functional recovery of the
      ankle after a telerehabilitation program compared to the usual treatment in patients with
      sprain grade 1-2 in the first level of care.

      Trial design: a controlled, randomized, pragmatic, single-blind and parallel clinical trial
      will be conducted. The independent variable will be the type of intervention
      (telerehabilitation vs usual care). The participants assigned to the telerehabilitation group
      will carry out a rehabilitation program using a mobile application, which will contain
      previously recorded videos with exercises that will serve as a guide for the rehabilitation
      activities. The duration of the program will be 30 minutes a day, 5 days a week for 4 weeks.
      The control group will be patients with usual care for ankle sprain, in the outpatient
      consultation of their medical care unit, they will receive instructions to follow from their
      doctors during the 4-week period.

      The dependent variable will be the functionality perceived by the patient. A collaborator
      will perform the group assignment, the initial assessment of ankle functionality perceived by
      the patient and the induction to the use of the application on the cell phone in the case of
      patients assigned to the intervention group. Subsequent (weekly) evaluations of functional
      perception of the ankle will be carried out by another collaborator who will be blinded and
      will not know to which group the evaluated patient belongs.

      The personnel who will invite and train patients to enter and use the telephone or internet
      application will be family medicine resident physicians.

      Methods.

      Scope of study: patients presenting in primary care for the diagnosis of AS grade 1 and 2.

      Experimental group (Telerehabilitation Group): Intervention. Rehabilitation service that will
      be provided remotely through information and communication technologies. It will start within
      the first 72 hours of having started with the condition (ankle sprain); they will receive a
      rehabilitation program using a mobile application (through a digital platform course), which
      will contain previously recorded videos with exercises that will serve as a guide for
      rehabilitation activities. The duration of the program will be 30 minutes a day, 5 days a
      week for 4 weeks. The control group will be patients with usual care for ankle sprain, in the
      outpatient consultation of their medical care unit, they will receive instructions to follow
      from their doctors during the 4-week period.

      The content of the rehabilitation program will consist of 2 modules: 1) Information module on
      the disease and self-care, 2) Exercise module (Stretching, strengthening and proprioception).
      The exercise program is based on the recommendations of national and international clinical
      practice guidelines. Additionally, the patient will be provided with a physical activity
      diary to assess adherence to treatment and the time the patient remains on the platform will
      be monitored.

      Control Group: Regular medical attention by family doctor. Care service that is carried out
      by the family doctor. The medical care that the patient with an ankle sprain will carry out
      with the family doctor; medical care will consist of the approach that the doctor considers
      appropriate for the patient. The follow-up and time of disability will be the responsibility
      of the doctor in question.

      Criteria for interrupting the assigned intervention:

        -  By request of the participant.

        -  Due to worsening of the condition.

      Strategies to improve compliance with the intervention: a weekly reminder will be made by
      phone call to patients.

      Interventions prohibited during the trial: perform other types of rehabilitation exercises
      that are not contemplated in the study.

      Sample size: to calculate the sample size, a clinical difference is considered in the Foot
      and Ankle Ability Measure (FAAM) based on the Hoch's study, where rehabilitation is performed
      in patients with chronic ankle instability based on joint mobilization, considering a minimal
      clinically important difference for measure ankle function at 4 weeks, having a result prior
      to the rehabilitation intervention of 78.27 in the activities of daily living (ADL) of Foot
      and Ankle Ability Measure (FAAM) (Standard Deviation 12.62) and post-intervention of 87.3
      (Standard Deviation 11.07), with a minimum detectable difference of 9.1 with a significance
      level of 5% and a power of 90%, performing a size calculation for the difference in paired
      means, with a consideration of estimated losses of 20%, so the sample size is 41 subjects per
      group.

      Recruitment: patients with a grade 1 and 2 ankle sprain diagnosis who have attended the
      family medicine consultation at Family Medicine Unit will be identified. Identification will
      be carried out through the medical information and clinical file area of the Unit. Patients
      will be contacted by phone and will be scheduled the next day. The number of patients
      diagnosed with AS is sufficient and frequent in the Unit.

      Allocation of interventions and blinding: it will be carried out by simple randomization; the
      randomization process will be carried out by an individual other than the one who will assign
      the groups. The randomization procedure will be generated with the Excel program; due to the
      nature of the intervention, the collaborator who will invite and enter the study subject
      cannot be blinded to the group assignment. Subsequent evaluations (weekly) where the response
      variables will be measured will be carried out by a different collaborator, who will be
      blinded from the group to which each study subject corresponds. The data analyst will remain
      blinded and will not know to which groups each study subject belongs. The circumstances that
      may unmask the data of the study subjects for both the evaluator and the data analyst, will
      be when the study subject is removed from the study for any reason.

      Data collection methods: to ensure the quality of the data obtained, the evaluators (resident
      physicians) will receive training to know and master the clinical scales. The monitoring of
      the intervention will be supervised by the responsible researcher. The input of the data
      obtained will be examined twice before being entered into the data matrix to verify its
      congruence, this review will be carried out by a collaborating researcher, all those data
      that are not plausible or outside the established ranges of values, they will have to be
      corroborated. It is considered to make phone calls and send text messages via cell phone to
      remind patients to carry out the rehabilitation exercises, in this way, promote the retention
      of patients in the study and achieve complete follow-up to the rehabilitation program.

      Data monitoring: the monitoring of the data will be carried out by the main researcher, who
      will not have contact with the study subjects, nor with the evaluators. Weekly, an
      intermediate analysis of the data obtained will be carried out by the main researcher, who
      will make the decision to end the study when the objectives are met.

      Damage: the study subjects will have the opportunity to report any type of adverse or
      unforeseen effect at any time, the report, if spontaneous, can be made by telephone to the
      collaborators or the principal investigator. In addition, in the weekly evaluation, there
      will be the opportunity to express any type of adverse event secondary to the rehabilitation
      maneuver. In case of corroborating any adverse effect secondary to the intervention, timely
      attention to the treating physician will be managed.

      Audit: the progress of the results will be audited by the project's tutorial committee every
      six months or when the project's tutor committee considers it. Progress in the results will
      be reported to the local ethics and institutional research committee every six months.

      Ethics and dissemination: it has the approval of the Local Ethics and Research Committee of
      the Mexican Institute of Social Security.

      Informed consent: informed consent will be obtained by the collaborators of the research
      project at the time of identifying and inviting the study subject, that is, it will not be
      obtained by the main researcher. The informed consent form is a document approved and granted
      by the Mexican Institute of Social Security, through the Ethics and Research Committee.

      Confidentiality: the data will be collected by the collaborators of the research project. The
      data will be collected in a single database to which, initially, only collaborators will have
      access, later it will be shared with the main researcher for data monitoring. The data will
      be kept in a computer equipment to which only the main investigator has access, for no reason
      will it be shared with personnel outside the study in order to maintain the confidentiality
      of the data before, during and after the trial.

      Data access: at the end of the trial, only researchers will be able to access the data.
      Collaborators will only know the final results.

      Additional and post-study care: the patients who have participated in the trial are
      guaranteed care within the health institution, so that attention to any damage suffered by
      the trial, will be followed and care. No additional compensation is established.
    

Intervention name(s): telerehabilitation
Intervention type(s): Other
Intervention description(s): It will start within the first 72 hours of having started with the condition (ankle sprain); They will receive a rehabilitation program using a mobile application (through a digital platform course), which will contain previously recorded videos with exercises that will serve as a guide for rehabilitation activities. The duration of the program will be 30 minutes a day, 5 days a week for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A controlled, randomized, pragmatic, single-blind and parallel clinical trial will be conducted. The independent variable will be the type of intervention (tele-rehabilitation vs usual care).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankle sprain; telerehabilitation; effectiveness