Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded 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
- 1
- 主要终点
- Change of self-reported pain on 100mm Visual Analogue Scale (VAS)
研究概览
简要总结
This study evaluates the effects of additional sensorimotor training (proprioceptive postural training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the participants will receive instructed treadmill training as an active comparator against PPT. All participants receive conventional physiotherapy as prescribed by their treating medical doctors. It is expected that the PPT group will improve in postural control, proprioceptive, as well as pain and function outcomes to a significantly greater extent than the active control group.
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
- 是
入选标准
- •Patients with musculoskeletal low back pain (non-specific low back pain)
- •Age ≥ 18 years
排除标准
- •Known or suspected neurological diseases or lesions
- •Traumatic injury of musculoskeletal system (fractures, tumours)
- •Spinal pathologies (e.g., tumour, infection, fracture, and inflammatory disease)
- •Previous spinal surgery
- •Presence of any contraindication to exercise (fracture or cardiovascular limitations)
研究组 & 干预措施
Sensorimotor
The experimental group will receive added PPT to the conventional physiotherapy. PPT will be applied by means of a neuro-orthopaedic medical device ("Posturomed®", see section 3.2). The "Posturomed" allows adaptive oscillation in the horizontal plane. Therapy instructions advise seven stages of difficulty. In all stages the patient is asked to provoke oscillation by stepping on site. After three steps, the patient must stand still on one leg for 2 seconds before he or she repeats the steps. Difficulty is increased by a) decreasing the damping through release of the breaks and b) through added juggling of a ball during the motor task (dual-task and divided attention). The next stage is reached once stabilisation in the previous stage is secured.
干预措施: Conventional physiotherapy (Other)
Sensorimotor
The experimental group will receive added PPT to the conventional physiotherapy. PPT will be applied by means of a neuro-orthopaedic medical device ("Posturomed®", see section 3.2). The "Posturomed" allows adaptive oscillation in the horizontal plane. Therapy instructions advise seven stages of difficulty. In all stages the patient is asked to provoke oscillation by stepping on site. After three steps, the patient must stand still on one leg for 2 seconds before he or she repeats the steps. Difficulty is increased by a) decreasing the damping through release of the breaks and b) through added juggling of a ball during the motor task (dual-task and divided attention). The next stage is reached once stabilisation in the previous stage is secured.
干预措施: Proprioceptive postural training (Other)
Low-intensity activity
Added to conventional therapy, as administered to all participants, the control group will do added treadmill walking. The control intervention will consist of 10 minutes of walking at comfortable pace. The patient will be instructed in treadmill functions and asked to set the speed between 2 and 4 km/h. The speed should be adjusted to the level where the patient would still be able to talk comfortably.
干预措施: Conventional physiotherapy (Other)
Low-intensity activity
Added to conventional therapy, as administered to all participants, the control group will do added treadmill walking. The control intervention will consist of 10 minutes of walking at comfortable pace. The patient will be instructed in treadmill functions and asked to set the speed between 2 and 4 km/h. The speed should be adjusted to the level where the patient would still be able to talk comfortably.
干预措施: Treadmill training (Other)
结局指标
主要结局
Change of self-reported pain on 100mm Visual Analogue Scale (VAS)
时间窗: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Change of functional status recorded with the Oswestry Disability Index (ODI)
时间窗: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
次要结局
- Centre of Pressure(Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))
- Joint Repositioning Error (segmental)(Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))
- Uncontrolled Manifold Index (UCM)(Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))
研究者
Michael A. McCaskey
Master of Science in Human Movement Science
Reha Rheinfelden