跳至主要内容
临床试验/NCT05696249
NCT05696249招募中不适用

The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Intra-abdominal pressure

研究概览

简要总结

The dissertation will focus on the possibilities of using pressure sensors during physiotherapy care. A single-blind randomized study will be conducted on a sample of at least 40 probands of working age with chronic LBP in the age range of 30-65 years. The following exclusive criteria are established: signs of serious spinal pathology (red flags), severe musculoskeletal trauma in the last year, vestibular, visual or neurological dysfunction affecting stability, ongoing pregnancy or breastfeeding, acute respiratory disease, cognitive dysfunction leading to misunderstanding of instructions and severe cardiac or internal disease. Inclusive and exclusive criteria will be evaluated by a rehabilitation doctor during a comprehensive examination before the start of therapy. All probands will undergo six-week outpatient therapy once a week. The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week. The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device. Before the start and at the end of the six-week therapy, all probands will be blindly evaluated for the quality of activation and use of intra-abdominal pressure with the DNS Brace device. At the same time, the Oswestry Disability Index questionnaire will be used to subjectively evaluate the probands before and after a series of therapies. The aim of the study is to demonstrate the possibility of using pressure sensors to improve the effect of physiotherapy.

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
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patient with chronic Low Back Pain
  • •age range of 30-65 years.

排除标准

  • •signs of serious spinal pathology (red flags)
  • •severe musculoskeletal trauma in the last year
  • •vestibular, visual or neurological dysfunction affecting stability
  • •ongoing pregnancy or breastfeeding
  • •acute respiratory disease
  • •cognitive dysfunction leading to misunderstanding of instructions
  • •severe cardiac or internal disease

研究组 & 干预措施

Group with an OhmTrak device

Experimental

The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week.

干预措施: OhmTrak device. (Device)

Group with an OhmTrak device

Experimental

The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week.

干预措施: Outpatient Physiotherapy (Other)

Group without an OhmTrak device

Other

The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device.

干预措施: Outpatient Physiotherapy (Other)

结局指标

主要结局

Intra-abdominal pressure

时间窗: six weeks

Before the start and at the end of the six-weeks therapy, all probands will be blindly evaluated for the quality of activation and use of intra-abdominal pressure with the DNS Brace device.

Oswestry Disability Index, Version 2.1a

时间窗: six weeks

Before the start and at the end of the six-weeks therapy, all probands will fill in the Oswestry Disability Index questionnaire to evaluate their subjective state before and after a series of therapies. A score of zero equals no disability and a score of 100 is the maximum possible disability.

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Use of Pressure Sensors in Functional Assessment... | 临床试验