- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03653299
Effects of Phototherapy on Gait and Balance of Post-stroke Individuals
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 01504-001
- Nove de Julho University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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 Names:
|
Experimental: 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. |
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 Names:
|
Experimental: 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. |
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 Names:
|
Experimental: 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. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Three-dimensional gait assessment
Time Frame: The test will be performed for five weeks
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The test will collect the kinetic data of gait, records the pressure center shifts and the foot contact time with the surface of platform.
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The test will be performed for five weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stabilometric assessment
Time Frame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
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The test will evaluate the static balance, on the force platform.
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The test will be performed for five weeks, twice a week, on the same day and time of the week.
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Functional balance assessment
Time Frame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
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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.
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The test will be performed for five weeks, twice a week, on the same day and time of the week.
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Static and dynamic balance assessment
Time Frame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
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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.
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The test will be performed for five weeks, twice a week, on the same day and time of the week.
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Functional mobility assessment
Time Frame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
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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.
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The test will be performed for five weeks, twice a week, on the same day and time of the week.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ernesto P Leal Junior, PhD, University of Nove de Julho
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP-211286
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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