Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients With Lumbar Spinal Stenosis With Neurogenic Claudication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change from baseline in walking capacity
研究概览
简要总结
The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.
The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being at least 50 years old
- •having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
- •having NC associated with LSS
- •being able to speak and understand French
- •being willing to attend 3 intervention sessions per week
- •with a duration of signs and symptoms of at least 3 months
- •(7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
- •being able to provide informed written consent.
排除标准
- •congenital LSS,
- •symptomatic osteoarthritis (hip or knee) causing limited walking capacity
- •neurological disease affecting walking capacity such as Parkinson
- •uncontrolled diabetes
- •heart failure
- •intermittent claudication of vascular origin
- •impaired cognitive capacity
- •back or lower extremities surgery in the past 3 months
研究组 & 干预措施
Intervention Group
Intervention group will received education and a specific rehabilitation program (exercises).
干预措施: Exercises and education (Other)
Control Group
Control group will received education alone.
干预措施: Education alone (Other)
结局指标
主要结局
Change from baseline in walking capacity
时间窗: Baseline, week 2, week 4, week 6, week 12
Walking capacity measure with the Self-Paced Walking Test (time)
次要结局
- Change from baseline in leg and back pain intensity(Baseline, week 2, week 4, week 6, week 12)
- Change from baseline in lower extremity physical function and balance(Baseline, week 6, week 12)
- Change from baseline in lumbar spinal stenosis related disabiltity(Baseline, week 6, week 12)
- Change from baseline in anxiety and depression(Baseline, week 6, week 12)
- Changes from baseline in self-efficacy(Baseline, week 6, week 12)
- Change from baseline in physical activity level(Baseline, week 6, week 12)
- Patient's global impression of change(changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12))
- Change from baseline in biomechanical parameters of gait(Baseline, week 2, week 4, week 6, week 12)
研究者
Martin Descarreaux
Professor
Université du Québec à Trois-Rivières