Acute Effects of Phototherapy With Combination of Super-pulsed Laser and LEDs on Gait and Balance of Post-stroke Individuals: A Randomized, Controlled and Triple-blind, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Three-dimensional gait assessment
研究概览
简要总结
Hemiparesis and/or hemiplegia is one of the most common clinical signs of stroke, characterized by partial or complete loss of motor function, resulting in varying degrees of impairment and disability. The aim of this study is evaluate the acute effects of application of phototherapy to detect if this therapeutic approach may be beneficial in gait and balance post-stroke individuals. For such, 10 volunteers, with a history of injury (stroke) between 6 months to 5 years, with deficit in functional capacity in the gait due spasticity of extensor muscles of the affected limb, specifically the Triceps Sural. The evaluation will consist of three-dimensional gait analysis, muscle activity during gait, mobility, static and functional balance, and mobility of volunteers.
详细描述
This is a clinical, randomized, placebo-controlled, crossover and triple-blind study. Ten participants with injury history (stroke) will perform the protocol. The intervention will be held once a week for 4 weeks. Each week a different dose of phototherapy (Placebo, 10J, 30J and 50J) will be applied. The phototherapy, active or placebo, will be applied in 9 different points of anterior muscle of the thigh, 6 different points of posterior muscle of the thigh and 2 different points of the gastrocnemius muscle, bilaterally, before the tests. Only one investigator, that will not participat in any phase of the assessments sessions, will know about what program is active or placebo in phototherapy device. Randomisation will occur by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. For three-dimensional gait assessment and muscle activity will be used a SMART-D system 140® - BTS Engineering with six cameras, two Kistler force platforms Platform model 9286BA and FREEEMG® electromyography - BTS Engineering wireless system with four channels. In addition, the evaluation will quantify the static balance (force platform), the functional balance (Berg Balance Scale) and mobility (6 minute walk test and go upand team test).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiparetic adults with a single stroke event, with crural predominance;
- •Injury (stroke) from 6 months to 5 years;
- •Aged between 40 and 60 years old;
- •In treatment at the Uninove physical therapy clinic;
- •Able to walk barefoot, with or without support;
- •With verbal comprehension, controlled systemic disease and clinically stable;
- •Able to perform the 6-minute walk test.
排除标准
- •Subjects with fixed deformities, previous surgery, previous osteoarticular dysfunction, any disease that influences the performance of the march;
- •Cognitive impairment detrimental to the tests;
- •Subjects who do not fit the inclusion criteria.
研究组 & 干预措施
Group A - Placebo, 10J, 30J and 50J
The phototherapy will be divided in programs 1, 2, 3 and 4. One of these programs will consist in placebo and the others in active phototherapy 10J, 30J and 50J.
The subjects allocated in group Phototherapy A will receive the programs in the following order 1, 2, 3 and 4, before the tests.
干预措施: Placebo or Active Phototherapy (MR4) (Device)
Group B - Placebo, 10J, 30J and 50J
The phototherapy will be divided in programs 1, 2, 3 and 4. One of these programs will consist in placebo and the others in active phototherapy 10J, 30J and 50J.
The subjects allocated in group Phototherapy B will receive the programs in the following order 2, 3, 4 and 1, before the tests.
干预措施: Placebo or Active Phototherapy (MR4) (Device)
Group C - Placebo, 10J, 30J and 50J
The phototherapy will be divided in programs 1, 2, 3 and 4. One of these programs will consist in placebo and the others in active phototherapy 10J, 30J and 50J.
The subjects allocated in group Phototherapy C will receive the programs in the following order 3, 4, 1 and 2, before the tests.
干预措施: Placebo or Active Phototherapy (MR4) (Device)
Group D - Placebo, 10J, 30J and 50J
The phototherapy will be divided in programs 1, 2, 3 and 4. One of these programs will consist in placebo and the others in active phototherapy 10J, 30J and 50J.
The subjects allocated in group Phototherapy D will receive the programs in the following order 4, 1, 2 and 3, before the tests.
干预措施: Placebo or Active Phototherapy (MR4) (Device)
结局指标
主要结局
Three-dimensional gait assessment
时间窗: The test will be performed for five weeks
The test will collect the kinetic data of gait, records the pressure center shifts and the foot contact time with the surface of platform.
次要结局
- Stabilometric assessment(The test will be performed for five weeks, twice a week, on the same day and time of the week.)
- Functional balance assessment(The test will be performed for five weeks, twice a week, on the same day and time of the week.)
- Static and dynamic balance assessment(The test will be performed for five weeks, twice a week, on the same day and time of the week.)
- Functional mobility assessment(The test will be performed for five weeks, twice a week, on the same day and time of the week.)
研究者
Adriane Aver Vanin
Principal Investigator
University of Nove de Julho