Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in postural stability on the platform, eyes closed
研究概览
简要总结
The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).
详细描述
The secondary objectives of this study are to evaluate and compare the two physical therapy techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms of:
A - improving postural stability and visual control on an unstable surface (with and without visual control)
B - improving levels of abdominal strength (Ito test) and erector spinae (Sørensen test)
C - the impact of back pain on daily life using questionnaires (Dallas, Québec, FABQ and Tampa questionnaires/scores)
D - Improvement of pain (Visual Analog Scale),
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 6 months of follow-up
- •Patients with pain in the lumbar spine (low back pain) for at least 3 months, not in connection with an operation
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient will have difficulties with follow-up (the patient is about to move, or isn't motivated)
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has already participated in a dynamic physical therapy program
- •The patient has a contraindication for a treatment used in this study
- •The patient has had surgery in the past year
- •The patient has a pathology that can interfere with the physical therapy regimen (heart failure, respiratory failure, major orthopedic problems)
研究组 & 干预措施
Routine Physical Therapy
Patients randomized to this arm will follow a classic, routine, physical therapy program.
Intervention: Routine Physical Therapy
干预措施: Routine Physical Therapy (Other)
I-Moove Physical Therapy
Patients randomized to this arm will follow a physical therapy program using the I-Moove device.
Intervention: I-Moove Physical Therapy
干预措施: I-Moove Physical Therapy (Device)
结局指标
主要结局
Change in postural stability on the platform, eyes closed
时间窗: Baseline to 6 weeks
次要结局
- Change in postural stability on the platform, eyes closed(Baseline to 6 months)
- Change in postural stability on the platform, eyes open(Baseline to 6 months)
- Change in postural stability on the platform, eyes open and with an unstable surface(Baseline to 6 months)
- Sorensen test(6 months)
- Visual analog scale for pain(6 months)
- Quebec questionnaire(6 months)
- Change in postural stability on the platform, eyes closed and with an unstable surface(Baseline to 6 months)
- Abdominal endurance: Ito test(6 months)
- Dallas questionnaire(6 months)
- FABQ questionnaire(6 months)
- Tampa Score(6 months)