跳至主要内容
临床试验/NCT05332080
NCT05332080已完成不适用

FUNCTIONAL RECOVERY AFTER A TELEREHABILITATION PROGRAM IN PATIENTS WITH DISTAL RADIUS FRACTURE: A RANDOMIZED CLINICAL TRIAL

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
Outcome of baseline measures of wrist function and changes at 4, 12 and 24 weeks

研究概览

简要总结

Objective: To determine the effectiveness of telerehabilitation versus supervised therapy in the functional recovery of patients with distal radius fracture.

Design: A randomized, controlled, parallel-treatment trial protocol was performed to compare functional recovery after a telerehabilitation program vs supervised rehabilitation in patients with distal radius fracture.

Setting:

Participants: A total of 91 patients with distal radius fractures grades AO23 A and B.

Interventions: the supervised rehabilitation group received for two weeks a 10-session program that included external heat application, stretching, mobilization, strengthening, and occupational therapy. The telerehabilitation group was given instructions to apply hydrotherapy, perform mobility and wrist and hand strengthening exercises for four weeks, using the Moodle application on their cell phone.

Main outcomes measures: Outcome measures were measured at the time of admission to rehabilitation and 1, 3, and 6 months; at each follow-up visit, functionality, active range of motion, fist grip strength, quality of life and pain were measured.

Results: When the results obtained at the beginning and at six months were compared, both groups presented statistically significant changes in the clinical variables analyzed but with greater functionality in the telerehabilitation group.

详细描述

Distal radius fractures (DRF) are among the most frequent fractures worldwide; in the United States, they are the second most common fracture in the upper limb, present an estimated annual incidence of 643,000 and represent 1.5% of consultations for hand and forearm fractures in emergency departments, after fractures of the radius and ulna. Their care implies an increase in the cost of care. In the United Kingdom, the National Health Services estimated an average expenditure of £1375.34 per day/patient, with surgical fixation of the FDR; in the USA, the Medicare system estimated a cost of more than $170 million for the care of these fractures. These patients are usually routinely referred to rehabilitation services after a variable period of immobilization, which increases the cost of care, with inpatient physiotherapy estimated to cost £82.03 per day and outpatient physiotherapy £40.70.

Despite various studies, it is still unclear which type of therapy has the most significant impact on the recovery of wrist function, range of motion, and strength. Currently, studies are showing that home programs are as effective as supervised rehabilitation programs; however, other studies show the opposite.

The Coronavirus disease (COVID-19) pandemic has imposed new paradigms of care for FDR, and now it is recommended to treat it as non-urgent and conservatively. Hence, it is necessary to establish rehabilitation strategies to continue caring for patients without exposing them to the risk of infection. In this sense, the World Confederation of Physical Therapy has proposed the digital practice of rehabilitation services (telemedicine). Therefore, the objective of this study was to determine the effectiveness of telerehabilitation versus supervised therapy in the functional recovery of patients with distal radius fractures.

Material and methods:

Approval was obtained for this study from the institutional review boards of the Hospital General Regional No.1 (R-2020-3201-153) and all patients consented to participate in the study and publication of the results.

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
None

入排标准

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

入选标准

  • Men and women older than 15 years
  • With closed distal radius fracture type AO23 A and B
  • Immobilization for six weeks (with or without surgical fixation)
  • With indication by the orthopedic physician to perform rehabilitation
  • Have a cell phone and internet access

排除标准

  • Patients with distal radius fractures with any of the following radiographic findings: volar tilt >12°, radial tilt >23° and radial height >12 mm
  • Patients with neurological problems, illiteracy, presence of pressure ulcers in the distal third of the forearm or hand that did not heal, users of orally or intravenously administered steroids, patients with pre-existing and concomitant arthritis or osteoarthritis of the wrist, or history of injury. Subjects with less than 80% adherence to treatment were eliminated.

结局指标

主要结局

Outcome of baseline measures of wrist function and changes at 4, 12 and 24 weeks

时间窗: At baseline and subsequently at 4, 12, and 24 weeks

The measures physical function and symptoms in people with musculoskeletal disorders of the upper limb, specifically the wrist, was measured with Disabilities of the Arm, Shoulder and Hand questionnaire, a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score test ranges from 0 (no disability) to 100 (most severe disability)

次要结局

  • Outcome of baseline measures of quality of life and changes at 4, 12 and 24 weeks(At baseline and subsequently at 4, 12, and 24 weeks)

研究者

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

Juan Figueroa-García

Principal investigator

Instituto Mexicano del Seguro Social

研究点 (2)

Loading locations...

相似试验