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临床试验/NCT06498453
NCT06498453已完成不适用

A Randomized Clinical Trial to Evaluate the Effectiveness of Telerehabilitation With Trak in Patients With Knee or Shoulder Pathology.

Trak Health Solutions S.L.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Escala DASH

研究概览

简要总结

The main objective of this clinical trial is to compare the effectiveness of digital physiotherapy treatment using the Trak telerehabilitation platform and the application of conventional means on two different health conditions (mild or moderate knee osteoarthritis and shoulder tendinopathy)

Participants will undergo telerehabilitation treatment through the TRAK platform for six weeks (treatment group) or follow the instructions and guidelines collected by health personnel for the same time in face-to-face rehabilitation sessions (control group).

详细描述

The recruitment process for this study is aimed at adults who suffer from musculoskeletal pathologies of the knee (mild or moderate osteoarthritis) or shoulder (tendinopathy).

After the initial screening, individuals who meet the study's predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants, ensuring ethical compliance and respect for individual autonomy.

The study cohort will consist of patients randomly assigned to the experimental group (EG) and the control group (CG) on both knee and shoulder groups. This randomised controlled trial has a parallel design with two groups. Regardless of group assignment, all patients will undergo baseline health assessments, ensuring that their individual needs are met. The satisfaction questionnaire will be deferred until post-intervention for both groups.

Patients will undergo 4 weeks of treatment through the TRAK tool (https://www.trakphysio.com/es/). Patients from the EG will carry out the treatment through the platform at home, and those from the CG will follow an on paper exercise protocol based on the usual (in-person) clinical practice methodology. Both groups will perform exercises in these rehabilitation sessions to improve shoulder mobility.

In phase 1 (3 weeks), all groups will undergo two weeks of in-person treatment based on established drainage technique and TENS application, ensuring the treatment's safety and efficacy. In addition, the patients will begin with in-person (CG) or remote treatment (EG), depending on the case. In the second phase or phase 2 (3 more weeks), patients will perform the exercises at home (EG) or at the medical center (CG).

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

入选标准

  • Patient over 18 years of age.
  • Patients with musculoskeletal pathology according to:
  • Knee: patients between 50 and 70 years old with a knee injury. Among the injuries Considered include mild or moderate osteoarthrosis and knee meniscopathies.
  • Shoulder: patients with shoulder tendonitis.
  • Patients with a tablet, smartphone or laptop who function agilely with the telematic technology necessary for the study.
  • Have an email account.
  • Understand the purpose of the study.
  • Signing of the informed consent.
  • Commitment to carry out the prescribed treatments.

排除标准

  • Patients with advanced cognitive impairment.
  • Patients with tendon tears or ruptures, in patients with shoulder tendinopathy.

结局指标

主要结局

Escala DASH

时间窗: Baseline and six months

It is used to measure the self-rated upper-extremity disability and symptoms.

Escala KOOS-PS

时间窗: Baseline and six months

It evaluates the patient's opinion about their knee and associated problems.

次要结局

  • Daniels scale(Baseline and six months)
  • EVA scale(Baseline and six months)
  • Trak designed a satisfaction questionnaire(Baseline and six months)
  • Limb mobility(Baseline and six months)

研究者

发起方
Trak Health Solutions S.L.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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