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临床试验/NCT06026137
NCT06026137招募中不适用

Use of the Efisiotrack System for Monitoring Prescribed Therapeutic Exercises in Patients With Shoulder Orthopedic Injuries in a Hospital Setting: a Pilot Feasibility Study

Universidad Miguel Hernandez de Elche2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Disabilities of Arm, Shoulder and Hand (DASH) score

研究概览

简要总结

To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.

详细描述

Patients who be referred to the rehabilitation service of the University Hospital of Elche (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study.

Patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception).

Following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. These will be performed independently by each patient in a hospital room without supervision by the physiotherapist.

The following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the Constant-Murley (CM) score.

All participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.

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
Double (Investigator, 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

入选标准

  • Be at least 18 years old and be able to read and understand Spanish.
  • Suffer a traumatic or degenerative shoulder injury, with or without surgical treatment.
  • Have a prescription for rehabilitative physical therapy that includes active exercises.

排除标准

  • Had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.

结局指标

主要结局

Disabilities of Arm, Shoulder and Hand (DASH) score

时间窗: At baseline and at one month follow-up.

DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.

次要结局

  • Constant-Murley (CM) score.(At baseline and at one month follow-up.)

研究者

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

JOSE VICENTE TOLEDO MARHUENDA

Principal Investigator

Universidad Miguel Hernandez de Elche

研究点 (2)

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