Effects of Phototherapy on Gait and Balance of Post-stroke Individuals
Condition: Post-stroke in Association to Phototherapy
MeSH terms: Stroke
Study type: Interventional

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).
    

Intervention name(s): Placebo or Active Phototherapy (MR4)
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: stroke; phototherapy; gait; balance; functional mobility