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临床试验/NCT06811090
NCT06811090已完成不适用

Effectiveness in Functional Recovery and Quality of Life After a Telerehabilitation Program for Patients With Ankle Fracture, Controlled Clinical Trial

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
functionality

研究概览

简要总结

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.

详细描述

Patients will be selected from the pelvic limb consultation, they will be invited to go to the tele-rehabilitation module where they will be taught the rehabilitation program that they must carry out, as well as written information about the program. Once the teaching is finished, they will be asked if they have any questions to clarify them. Once the teaching is finished, they will be followed up through the Moodle platform to see their clinical evolution and identify the date of their discharge from work. Later, this group will be compared with the patients who carried out their rehabilitation treatment in the usual way.

Randomization Randomization will be carried out through a software-based randomization program. The assignment will be done by balanced random blocks, block size 8, with an assignment ratio of 1:1. The recruitment of participants, the assignment of participants to the interventions and the evaluations will be carried out by medical evaluators.

Blinding of subjects, therapists and evaluators: Due to the nature of the intervention, it is not possible to blind participants and therapists. However, the initial and final evaluators will not be aware of the treatment group to which the study subject belongs, and the statistical analysis will be performed in a blinded manner, only the treatment will be mentioned as Group A or Group B

Data quality: Several strategies will be implemented to ensure data quality. All procedures will be adjusted with the standard operating procedures of the North Physical Medicine and Rehabilitation Unit. Evaluators and treating physiotherapists will receive appropriate training before working. Compliance with the intervention follow-up will be closely monitored by a research associate in the Physical Medicine and Rehabilitation Unit and on the platform. Forms and data processing will be periodically reviewed for accuracy. All data entry will be double-checked for accuracy.

Intervention Experimental group: Tele-Rehabilitation Group (Online Exercise and Counseling) Conceptual definition: Rehabilitation service that is provided remotely through information and communication technologies. In this case it will be carried out online through the Moodle platform.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Hospital rehabilitation (Other)

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.

干预措施: Tele-rehabilitation (Other)

结局指标

主要结局

functionality

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

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')

Quality of Life - SF-12 health questionnaire

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

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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Daniel Martínez Barro

MÉDICO NO FAMILIAR

Instituto Mexicano del Seguro Social

研究点 (1)

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