Functional Ankle Recovery After a Telerehabilitation Program for Patients With Sprain in the First Level of Care, Controlled Clinical Trial and Cost-effectiveness Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Days of incapacity for work indicated by the doctor
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Due to the nature of the maneuver, 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.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Beneficiaries of the Mexican Institute of Social Security
- •Patients with grade 1 and 2 ankle sprain, and are within the first 72 hours of presenting it
- •Over 18 years of age and under 61 (this age group is susceptible to receiving monetary transfers for medical disability due to being of working age).
- •Who have formal employment with susceptibility to receive medical disability.
- •That they agree to participate in the study and sign the informed consent.
- •With a diagnosis of ankle sprain for the first time.
- •That they have and know how to use a cell phone or computer, as well as its use with the internet.
Exclusion Criteria
- •- With a history of previous ankle sprain.
- •With time greater than 72 hours after starting with the ankle sprain.
- •Patients with neurological disorders.
- •Patients who cannot read or write.
- •Retired patients.
- •With leg or foot ulcers.
- •Users of steroids administered orally or intravenously.
- •Pre-existing and concomitant ankle arthritis or history of significant ipsilateral or contralateral lower extremity injury / condition, eg. lower extremity joint prostheses, or central or peripheral neurological disorders.
- •Fibromyalgia
- •Neuromuscular plaque disease
Arms & Interventions
Intervention group
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 content of the rehabilitation program will consist of e modules: 1) Information module on the disease and self-care, 2) Exercise module (Stretching, strengthening and proprioception).
Intervention: telerehabilitation (Other)
Control group
Care service that is carried out by the Family Physician. The medical care that the patient with an ankle sprain will carry out with the Family Physician of the assigned office; 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 Physician in question
Outcomes
Primary Outcomes
Days of incapacity for work indicated by the doctor
Time Frame: They will be quantified from the first day after presenting the ankle sprain, until completing 4 weeks after being admitted to the study.
The days of incapacity for work indicated by the treating physician to the study subject will be quantified, since the patient presented the ankle sprain, until completing 4 weeks from their entry into the study. This data will be obtained from the patient's electronic clinical record. The quantification of days of incapacity for work will be taken into account in both groups (intervention and control).
Ankle functionality perceived by the patient with foot and ankle ability measure
Time Frame: Within the first 72 hours of starting with the ankle sprain (baseline measurement) and thereafter, every week (for 4 weeks), until one month after entering the study
The Foot and Ankle Ability Measurement (FAAM) is a self-report outcome instrument developed to assess the physical function of individuals with foot and ankle-related impairments. It is a 29-item questionnaire divided into two subscales: 1) Activities of Daily Living (ADL) with 21 items and the Sports subscale with 8 items. Each item is rated on a 5-point Likert scale (4 to 0) from "no difficulty at all" to "unable to do". Total item scores, range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were converted into percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and a lower score is indicative of decreased function. The FAAM is reliable (ADL: ICC=0.89; Sport: ICC=0.087), valid and responsive to change after intervention. This measurement will be made in both groups (intervention and control).
Secondary Outcomes
- Weekly minutes allocated to rehabilitation activities(The quantification of minutes will be carried out from the beginning of the study, every week, for 4 weeks.)
- Change in Visual Analog Scale(Within the first 72 hours of starting with the ankle sprain (baseline measurement) and thereafter, every week (for 4 weeks), until one month after entering the study)
Investigators
Juan Figueroa-García
Principal Investigator
Instituto Mexicano del Seguro Social