Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- balance
研究概览
简要总结
Purpose of the study: To analyse the effectiveness of aquatic physiotherapy on spinal cord injuries (LMi) in the improvement of balance and gait, in the inflammatory profile, and the impact on the quality of life.
Main objective: To analyse if there are differences in the recovery of the balance, in incomplete subacute spinal cord injuries, with lesion level T1-L5 and ASIA (American Spinal Injury Association) C and D .
Secondary objectives:
- functional gait
- To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait.
- To study the effect of aquatic therapy on serum markers of systemic inflammation.
- Quality of life related to health. Design: Crossed, controlled and randomized clinical trial, with blind evaluation of the response variables.
Scope of the study: National Hospital of Paraplegics. Toledo (Spain). Population: Subjects with incomplete spinal cord injury ASIA C and D. n = 50 (25 in each arm randomly).
Intervention:
6 weeks of specific Aquatic Physiotherapy (3 times a week). Group 1 will perform aquatic physiotherapy at the time of entering the study, and group 2 will perform it 6 weeks later.
Outcomes: Static and dynamic balance (Berg test and Time Up and Go). Speed of the gait (test of 10 m.). Gait resistance (6 min. Test). Functional capacity of the gait (WISCI II). Biomechanical analysis (sensorial-dynamic, rhythmic and directional control, and gait test) by posturography. Questionnaires EuroQol-5Dimensions-5Level (EQ-5D-5L) and the Spanish Version of the Quality of Life Index (SV-QLI) in spinal cord injury (SCI).
Biomarkers of inflammation: 20 cytokines. Analysis of results: The main outcome measure will be the percentage of patients who have improved. Considering improvement when the difference between the groups is, at least, a 10% of their score in the Berg test between V0 and V1 (with their corresponding 95% confidence intervals). It will be adjusted for confounding and interaction factors with a multivariate analysis using logistic regression. All analyses will be performed according to the intention to treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Subjects with incomplete spinal cord injury T1-L5 (ASIA C y D).
- •Traumatic and not traumatic injuries, with injury date of less than 8 months.
- •Able to maintain assisted standing up
- •Subjects signing the informed consent form
排除标准
- •Subjects with progressive injuries.
- •heart or lung disease
结局指标
主要结局
balance
时间窗: 12 weeks
Berg test
Speed of the gait
时间窗: 12 weeks
test of 10 m
Gait resistance
时间窗: 12 weeks
6 Minutes Walk Test
Functional capacity of the gait
时间窗: 12 weeks
Walking Index for spinal cord injury (WISCI II)
次要结局
- General quality of life related to Health(12 weeks)
- Specific quality of life related to health in spinal cord injury(12 weeks)
- Inflammatory cytokines analysis(12 weeks)