Post-stroke in Association to PhototherapyNCT03653299
Effects of Phototherapy on Gait and Balance of Post-stroke Individuals
A study of Post-stroke in Association to Phototherapy, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Post-stroke in Association to Phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jun 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Being tested
- Placebo or Active Phototherapy (MR4)
- Keywords
- stroke, phototherapy, gait, balance, functional mobility
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo or Active Phototherapy (MR4)Device
Also called MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Placebo, 10J, 30J and 50J | Experimental | 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. Receives: Device: Placebo or Active Phototherapy (MR4) |
| Group B - Placebo, 10J, 30J and 50J | Experimental | 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. Receives: Device: Placebo or Active Phototherapy (MR4) |
| Group C - Placebo, 10J, 30J and 50J | Experimental | 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. Receives: Device: Placebo or Active Phototherapy (MR4) |
| Group D - Placebo, 10J, 30J and 50J | Experimental | 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. Receives: Device: Placebo or Active Phototherapy (MR4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The test will be performed for five weeks
Secondary outcomes (4)
Stabilometric assessment
The test will evaluate the static balance, on the force platform.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The test will be performed for five weeks, twice a week, on the same day and time of the week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start13 Jun 2016
- Primary completion18 May 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-stroke in Association to PhototherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Adriane Aver Vanin, University of Nove de Julho
- Investigators
- Ernesto P Leal Junior, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653299
- Sponsor's protocol ID
- CEP-211286
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24249354Antonialli 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.
PubMed 24942380
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03653299
- Acronym / sponsor ID
- CEP-211286
- Keywords
- stroke, phototherapy, gait, balance, functional mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A - Placebo, 10J, 30J and 50J | Experimental | Device: Placebo or Active Phototherapy (MR4)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 B - Placebo, 10J, 30J and 50J | Experimental | Device: Placebo or Active Phototherapy (MR4)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 C - Placebo, 10J, 30J and 50J | Experimental | Device: Placebo or Active Phototherapy (MR4)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 D - Placebo, 10J, 30J and 50J | Experimental | Device: Placebo or Active Phototherapy (MR4)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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo or Active Phototherapy (MR4)Also: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)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. | Device | Group A - Placebo, 10J, 30J and 50J, Group B - Placebo, 10J, 30J and 50J, Group C - Placebo, 10J, 30J and 50J, Group D - Placebo, 10J, 30J and 50J |
Primary outcome
Three-dimensional gait assessment
Time frame: The test will be performed for five weeks
The test will collect the kinetic data of gait, records the pressure center shifts and the foot contact time with the surface of platform.
4 secondary outcomes
Stabilometric assessment
Time frame: The test will be performed for five weeks, twice a week, on the same day and time of the week.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Background: PubMed 24249354Leal-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.
- Background: PubMed 24942380Antonialli 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernesto P Leal Junior, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Post-stroke in Association to Phototherapy, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional gait assessment (time frame: The test will be performed for five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653299, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.