Effectiveness of a Telerehabilitation Program in Ankle Sprain

NCT05217173 | Completed

• 1 other identifier: R-2021-3609-037
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprain; Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree

Keywords

ankle sprain; telerehabilitation; effectiveness

Outcome Measures

Primary Outcomes (2)

• Ankle functionality perceived by the patient with foot and ankle ability measure

  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).

  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

• Days of incapacity for work indicated by the doctor

  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).

  They will be quantified from the first day after presenting the ankle sprain, until completing 4 weeks after being admitted to the study.

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Other: telerehabilitation

Control group

NO INTERVENTION

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

Interventions

telerehabilitation OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Unidad de Medicina Familiar 21

Iztacalco, Mexico City, 08300, Mexico

Location

Related Publications (30)

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Related Links

• Journal of Family Medicine Andalusian from Spain
• is a guide of clinical practice of Mexican Institute of Social Security

MeSH Terms

Conditions

Ankle Injuries

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)