Telerehabilitation in Patients With Ankle Fracture

NCT06811090 | Completed

• 1 other identifier: R-2020-3401-024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to determine the effectiveness of a telerehabilitation program in the recovery of functionality and quality of life in patients recovering from ankle fracture. The main questions to be answered are: What is the effectiveness of a telerehabilitation program in the recovery of functionality in patients with ankle fracture? What is the effectiveness of a telerehabilitation program in the recovery of quality of life in patients with ankle fracture? The researchers will compare the telerehabilitation program against the usual hospital rehabilitation procedure to see if there are differences in functional recovery and quality of life. Participants will take a telerehabilitation program at home with the help of smartphones or will be sent to the usual hospital procedure for in-person rehabilitation. They will have monthly in-person follow-up until 3 months, and by telephone at 6 months for the evaluation of their functionality and quality of life.

Conditions

Ankle Fracture

Keywords

ankle fracture; tele-rehabilitation; functionality; quality of life

Outcome Measures

Primary Outcomes (2)

• functionality

  Rating obtained through the functional foot index. The participant rates the degree of difficulty in performing 23 different functional activities on a 10-point scale ranging from 0 ('no difficulty') to 10 ('extreme difficulty or inability to perform activity')

  From admission, and with evaluations at the first, second and third month

• Quality of Life - SF-12 health questionnaire

  The score obtained by the SF12 survey, which is designed to measure health-related quality of life and be the descriptive system for a multi-attribute utility instrument. The SF-12 response options are based on Likert-type scales that assess intensity or frequency. Each question is assigned a score, which is transformed into a scale from 0 to 100. The scores have a mean of 50 with a standard deviation of 10, so scores above or below 50 indicate better or worse health, respectively, than the reference population.

  From admission, and with evaluations at the first, second and third month

Study Arms (2)

Hospital rehabilitation

ACTIVE COMPARATOR

Rehabilitation program that will be carried out in person at the North Physical Medicine and Rehabilitation Unit. The program will be carried out by a physiotherapist and the patient will be taught: Information about the disease and self-care, Exercise module (stretching, strengthening and proprioception), gait re-education in phases.

Other: Hospital rehabilitation

Tele-rehabilitation

EXPERIMENTAL

The Moodle application will be installed on your mobile phone to access the online content that will be integrated into three modules: 1) Information module on the disease and self-care, 2) Exercise module (stretching, strengthening and proprioception), 3) Phased walking module. Which will be integrated with video and text.

Other: Tele-rehabilitation

Interventions

Tele-rehabilitation OTHER

Rehabilitation service provided remotely through information and communication technologies.

Tele-rehabilitation

Hospital rehabilitation OTHER

Rehabilitation program that will be carried out in person at the North Physical Medicine and Rehabilitation Unit. The program will be carried out by a physiotherapist and the patient will be taught: Information about the disease and self-care, Exercise module (Stretching, strengthening and proprioception), and phased gait re-education.

Hospital rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IMSS beneficiaries treated at HTVFN for ankle fractures, over 18 years of age, discharged and referred to Rehabilitation
• WEBER A, B, and C fractures, conservative or surgical management
• Removal of immobilization
• Partial weight bearing indicated
• Access to telephone with internet (independent or with family support)

You may not qualify if:

• Inability to complete a quality of life/functionality questionnaire Disability that limits compliance with instructions for completing a rehabilitation program at home or in an institutional setting
• Elimination Criteria Loss to follow-up or individuals who wish to withdraw from the clinical study.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Unidad Médica de Alta Especialidad (UMAE) de Traumatología, Ortopedia y Rehabilitación "Dr. Victorio de la Fuente Narváez",

México, GUSTAVO A MADERO, 07760, Mexico

Location

Related Publications (3)

• Tenforde AS, Iaccarino MA, Borgstrom H, Hefner JE, Silver J, Ahmed M, Babu AN, Blauwet CA, Elson L, Eng C, Kotler D, Homer S, Makovitch S, McInnis KC, Vora A, Borg-Stein J. Telemedicine During COVID-19 for Outpatient Sports and Musculoskeletal Medicine Physicians. PM R. 2020 Sep;12(9):926-932. doi: 10.1002/pmrj.12422. Epub 2020 Jul 10.

  PMID: 32424977 BACKGROUND

• Buker N, Savkin R, Ok N. Comparison of Supervised Exercise and Home Exercise After Ankle Fracture. J Foot Ankle Surg. 2019 Sep;58(5):822-827. doi: 10.1053/j.jfas.2018.11.021.

  PMID: 31474396 BACKGROUND

• Moseley AM, Beckenkamp PR, Haas M, Herbert RD, Lin CW; EXACT Team. Rehabilitation After Immobilization for Ankle Fracture: The EXACT Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1376-85. doi: 10.1001/jama.2015.12180.

  PMID: 26441182 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures

Interventions

Telerehabilitation; Hospitals, Rehabilitation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg 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; Hospitals, Special; Hospitals; Health Facilities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MÉDICO NO FAMILIAR

Model Details: Tele-Rehabilitation Group (Online Exercise and Counselling) Conceptual definition: Rehabilitation service provided remotely through information and communication technologies. In this case, it will be carried out online through the Moodle platform.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 18, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

ME (1)