Effects of Phototherapy on Gait and Balance of Post-stroke Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Post-stroke in Association to Phototherapy

Intervention / Treatment
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* Device: Placebo or Active Phototherapy (MR4)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Placebo, 10J, 30J and 50J<br>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. | Device: Placebo or Active Phototherapy (MR4)<br>* Phototherapy, placebo or active, will 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. Once a week during for 4 weeks, before the tests, the phototherapy programs (1, 2, 3 and 4) order will depend of the group randomized. The 10 subjects will do the three-dimensional gait analysis, muscle activity during gait, evaluation of mobility, static and functional balance, and mobility tests.<br>* Other names: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA);|
| Experimental: Group B - Placebo, 10J, 30J and 50J<br>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. | Device: Placebo or Active Phototherapy (MR4)<br>* Phototherapy, placebo or active, will 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. Once a week during for 4 weeks, before the tests, the phototherapy programs (1, 2, 3 and 4) order will depend of the group randomized. The 10 subjects will do the three-dimensional gait analysis, muscle activity during gait, evaluation of mobility, static and functional balance, and mobility tests.<br>* Other names: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA);|
| Experimental: Group C - Placebo, 10J, 30J and 50J<br>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. | Device: Placebo or Active Phototherapy (MR4)<br>* Phototherapy, placebo or active, will 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. Once a week during for 4 weeks, before the tests, the phototherapy programs (1, 2, 3 and 4) order will depend of the group randomized. The 10 subjects will do the three-dimensional gait analysis, muscle activity during gait, evaluation of mobility, static and functional balance, and mobility tests.<br>* Other names: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA);|
| Experimental: Group D - Placebo, 10J, 30J and 50J<br>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. | Device: Placebo or Active Phototherapy (MR4)<br>* Phototherapy, placebo or active, will 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. Once a week during for 4 weeks, before the tests, the phototherapy programs (1, 2, 3 and 4) order will depend of the group randomized. The 10 subjects will do the three-dimensional gait analysis, muscle activity during gait, evaluation of mobility, static and functional balance, and mobility tests.<br>* Other names: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-dimensional gait assessment | The test will collect the kinetic data of gait, records the pressure center shifts and the foot contact time with the surface of platform. | The test will be performed for five weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stabilometric assessment | The test will evaluate the static balance, on the force platform. | The test will be performed for five weeks, twice a week, on the same day and time of the week. | 
| Functional balance assessment | The functional assessment will be composed for one test: Berg Balance Scale (BBS). The BBS is a widely used clinical test developed for evaluate of a persons static and dynamic balance abilities, for functional balance tests,is generally considered the gold standard. The scale comprises a test with a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of 0 (unable) to 4 (independent), and the final measure is the sum of all of the scores, it test takes 10 - 15 minutes. The interpretation of the results is: ≤20 limited data from subjects, that suggest that the tool might have similar absolute reliability at the low and high ends. Normal values = People aged 69 years without any health conditions likely to affect mobility can be expected to have a BBS score of 56/56. This normal value declines with increasing age, at a rate of 0.75 points per year. | 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 static and dynamic balance assessment will be composed for one test: Timed up and go test - test used to evaluate a person's mobility and requires static and dynamic balance. | The test will be performed for five weeks, twice a week, on the same day and time of the week. | 
| Functional mobility assessment | The functional mobility assessment will be composed for one test: 6-minute walk test (6MWT) - The 6MWT is used as a one-time measure of functional mobility status of patients. It's a practical test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians for the evaluation of functional exercise capacity. | The test will be performed for five weeks, twice a week, on the same day and time of the week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, stroke, phototherapy, gait, functional mobility