Clinical trial NCT03653299: Effects of Phototherapy on Gait and Balance of Post-stroke Individuals
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke in Association to Phototherapy
Keywords: stroke
phototherapy
gait
balance
functional mobility
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Three-dimensional gait assessment
timeFrame: The test will be performed for five weeks
Secondary outcomes:
measure: Stabilometric assessment
timeFrame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
measure: Functional balance assessment
timeFrame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
measure: Static and dynamic balance assessment
timeFrame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
measure: Functional mobility assessment
timeFrame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: University of Nove de Julho
name: Ernesto P Leal Junior, PhD
role: STUDY_DIRECTOR
References:
citation: Leal-Junior EC, Vanin AA, Miranda EF, de Carvalho Pde T, Dal Corso S, Bjordal JM. Effect of phototherapy (low-level laser therapy and light-emitting diode therapy) on exercise performance and markers of exercise recovery: a systematic review with meta-analysis. Lasers Med Sci. 2015 Feb;30(2):925-39. doi: 10.1007/s10103-013-1465-4. Epub 2013 Nov 19.
citation: Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.