NCT05910463招募中不适用
Assessment of the Impact of the Axomove Therapy® Medical Device on Subacute or Chronic Low Back Pain Patients Leaving Rehabilitation Centres to Facilitate Self-rehabilitation: a Multicentre Randomized Controlled Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Axomove
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Efficacy of AXOMOVE Therapy
研究概览
简要总结
An evaluation study of the impact of the Axomove Therapy® medical device on subacute or chronic low back pain patients leaving rehabilitation centres to facilitate self-rehabilitation. A prospective, randomized, open-label, multicentre study whose main objective is to evaluate the effectiveness of the Axomove Therapy Medical Device on disability reduction (Oswestry disability index score) patients with subacute or chronic low back pain requiring rehabilitation.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18-65 years,
- •Patients with subacute or chronic low back pain, day hospital follow-up (HDJ) or weekday hospital with a planned return home within 2 weeks of the inclusion visit (J0), Patient with common low back pain for at least 6 weeks before hospitalization, Patient having a smartphone, tablet/ or computer (compatible with the technical requirements of the DM) and having the possibility to connect (via a telephone subscription or a WIFI connection),
- •Patient agreeing to install the Axomove Therapy® application and agreeing to follow the study protocol,
- •Patient with physical, sensory and cognitive ability to use an application (digital tools) on a smartphone, tablet or computer and perform physical exercise programs,
- •A patient who is a member of, or in receipt of, a social security scheme.
排除标准
- •Patients who are unable to understand, read or speak French,
- •Inability to receive informed information,
- •A patient with a sensory, visual or tactile impairment that prevents the correct use of a smartphone, tablet and/or computer, or prevents the exercise from being carried out safely,
- •Patient with suspected or proven serious pathology such as recent vertebral fractures (less than 6 months), infection, malignant tumors and/or radiculopathy,
- •Patient with a history of rheumatic inflammatory disease,
- •Patient with true radiculalgia,
- •Patient with scoliosis > 30°, Patient with lumbar surgery in the past 12 months,
- •Pregnant patient, parturient or breastfeeding,
- •Patient under legal protection (guardianship, curatorship),
- •A patient with a serious and/or uncontrolled illness that, in the opinion of the investigator, could result in unacceptable safety risks or compromise protocol compliance, for example: an active or uncontrolled infection.
结局指标
主要结局
Efficacy of AXOMOVE Therapy
时间窗: 14 weeks (105 days)
Functional capacity of patients measured through the Oswestry Disability Index score
次要结局
- Efficacy of AXOMOVE Therapy(day 0 (inclusion), day 15, day 45)
- Level of patient physical activity(day 0 (inclusion), day 15, day 45 and day 105)
- Quality of life(day 0 (inclusion), day 15, day 45 and day 105)
研究者
研究点 (2)
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