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

NCT ID: NCT03653299

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-13
• Study Completion Date: 2018-06-01

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).

Conditions

Post-stroke in Association to Phototherapy

Keywords

stroke; phototherapy; gait; balance; functional mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Placebo or Active Phototherapy (MR4)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Placebo or Active Phototherapy (MR4)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Placebo or Active Phototherapy (MR4)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Placebo or Active Phototherapy (MR4)

Intervention Type: DEVICE

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.

Interventions

Placebo or Active Phototherapy (MR4)

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.

Intervention Type: DEVICE

Other Intervention Names

MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Adriane Aver Vanin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernesto P Leal Junior, PhD

Role: STUDY_DIRECTOR

University of Nove de Julho

Locations

Nove de Julho University

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 24249354 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24942380 (View on PubMed)

Other Identifiers

CEP-211286

Identifier Type: -

Identifier Source: org_study_id