FatigueNCT03753984
Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals
A study testing Low-level laser therapy in people with Fatigue and Stroke Sequelae, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial summary
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Stroke Sequelae
- What is being tested?
- Low-level laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 1 Mar 2020
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preserved cognition, and preservation of the ability to respond to verbal stimul;
- To present the "insufficient active" or "active" indices on the scale of the International Questionnaire of Physical Activity.
- Individuals with medical diagnosis of stroke;
- Individuals with physiotherapeutic diagnosis of spastic hemiparesis with brachial predominance;
- Preserved cognition and preservation of the ability to respond to verbal stimuli;
- Injury time: after 12 months;
- Patients with a maximum of 2 degree spasticity according to the Modified Ashworth Scale and minimum muscle strength of 1 in the biceps brachii muscle.
Who cannot join
- Possess musculoskeletal impairment of the dominant upper limb;
- Practice physical activity with load (bodybuilding);
- Presence of active infection and eruptions in the dominant upper limb;
- Limiting pain that makes it impossible to perform the evaluation protocol;
- Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing corticosteroids or steroids.
- Fitzpatrick classification: Phototypes V and VI;
Show all 20Show fewer
- Presence of malignant neoplastic lesion;
- Presence of active infection and eruptions at the electrode application site;
- Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb in which TLBI will be applied.
- Presence of active infection and eruptions in the dominant upper limb;
- Limiting pain that makes it impossible to perform the evaluation protocol;
- Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing corticosteroids or steroids.
- Fitzpatrick classification: Phototypes V and VI;
- Presence of malignant neoplastic lesion;
- Presence of active infection and eruptions at the electrode application site;
- Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb to be treated;
- Muscular contractures and joint deformities;
- Uncontrolled arterial hypertension;
- Individuals with other associated neurological and / or orthopedic disorders;
- Wernick or Broca's aphasia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Vale do Paraiba
São José dos Campos, São Paulo, 12.244-000
Gabriela S Souza, 5512997232806, gabrielasouza507@yahoo.com.br
About this study
Official title: Analysis of the Effects of Low-level Laser Therapy in the Muscular Fadiga of the Braquial Biceps Muscle of Healthy Individual and Spastic Individuals
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis. The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization. The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. Will be evaluated pain, myoelectric activity associated with muscular torque, local temperature and blood lactate concentration.
Read the detailed description
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. Several resources are studied in order to mitigate this situation, among them we can mention the Low Level-Laser Therapy (LLLT), which has demonstrated positive effects in the treatment of muscle disorders and fatigue prevention. The effects of LLLT are being studied in healthy individuals with fibromyalgia and athletes, currently studies are being performed on spastic muscles with post-stroke patients (post-stroke). The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis. A double-blind, cross-sectional, comparative, randomized, double-blind clinical trial will be conducted. Phase I will consist of 30 healthy individuals and Phase II will be composed of 30 post-stroke individuals. The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization. The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. The pain intensity will be evaluated through the Visual Analog Pain Scale, the myoelectric activity through the surface electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer. The local temperature will be evaluated by infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC.
- Conditions
- Fatigue, Stroke Sequelae
- Being tested
- Low-level laser therapy
- Keywords
- Fatigue, Low-level Laser Therapy, Stroke, Infrared thermograpy
- Medical subject headings
- Fatigue, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyOther
In both arms will be applied Low-level laser therapy and induced muscle fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Experimental | The protocol consists of Low-level laser therapy (LLLT) application in the dominant side brachialis muscle in healthy subjects prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT). Receives: Other: Low-level laser therapy |
| Post stroke group | Experimental | The protocol consists of Low-level laser therapy (LLLT) application in the hemiparetic side brachialis muscle post stroke individuals prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, surface electromyography with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT). Receives: Other: Low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain sensation
To analize the pain. The scale is composed of a horizontal line with a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.
Measured: Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
Surface electromyograph
To analize the myoelectric activity. The surface electrodes will be placed in pairs on the muscular belly of the biceps and triceps brachii muscles, following the longitudinal direction of the muscle fibers.
Measured: Will be assessed from the beginning to the end of the test (50 seconds).
Analyze the behavior of the local temperature (Infra-red thermography)
To analize the local temperature.
Measured: Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
To evaluate changes in lactate concentration through lactimeter.
A collection of blood lactate levels will be performed at four different times.
Measured: Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
Isokinetic dynamometer
To analize muscle torque
Measured: Will be assessed from the beginning to the end of the test (50 seconds).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Sep 2018
- Primary completion1 Jun 2019
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernanda P Lima, Doctor, Principal investigator, Universidade do Vale do Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753984
- Sponsor's protocol ID
- UNIVAP
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effects of Low-level Laser Therapy in the Muscular Fadiga of the Braquial Biceps Muscle of Healthy Individual and Spastic Individuals
- ClinicalTrials.gov ID
- NCT03753984
- Acronym / sponsor ID
- UNIVAP
- Conditions
- Fatigue, Stroke Sequelae
- Keywords
- Fatigue, Low-level Laser Therapy, Stroke, Infrared thermograpy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 27 Nov 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.
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis. The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization. The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. Will be evaluated pain, myoelectric activity associated with muscular torque, local temperature and blood lactate concentration.
Detailed description
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. Several resources are studied in order to mitigate this situation, among them we can mention the Low Level-Laser Therapy (LLLT), which has demonstrated positive effects in the treatment of muscle disorders and fatigue prevention. The effects of LLLT are being studied in healthy individuals with fibromyalgia and athletes, currently studies are being performed on spastic muscles with post-stroke patients (post-stroke). The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis. A double-blind, cross-sectional, comparative, randomized, double-blind clinical trial will be conducted. Phase I will consist of 30 healthy individuals and Phase II will be composed of 30 post-stroke individuals. The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization. The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. The pain intensity will be evaluated through the Visual Analog Pain Scale, the myoelectric activity through the surface electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer. The local temperature will be evaluated by infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | Experimental | Other: Low-level laser therapyThe protocol consists of Low-level laser therapy (LLLT) application in the dominant side brachialis muscle in healthy subjects prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT). |
| Post stroke group | Experimental | Other: Low-level laser therapyThe protocol consists of Low-level laser therapy (LLLT) application in the hemiparetic side brachialis muscle post stroke individuals prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, surface electromyography with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (20 listed)
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 |
|---|---|---|
| Low-level laser therapyIn both arms will be applied Low-level laser therapy and induced muscle fatigue. | Other | Healthy group, Post stroke group |
Primary outcome
Changes in pain sensation
Time frame: Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
To analize the pain. The scale is composed of a horizontal line with a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.
Surface electromyograph
Time frame: Will be assessed from the beginning to the end of the test (50 seconds).
To analize the myoelectric activity. The surface electrodes will be placed in pairs on the muscular belly of the biceps and triceps brachii muscles, following the longitudinal direction of the muscle fibers.
Analyze the behavior of the local temperature (Infra-red thermography)
Time frame: Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
To analize the local temperature.
To evaluate changes in lactate concentration through lactimeter.
Time frame: Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
A collection of blood lactate levels will be performed at four different times.
Isokinetic dynamometer
Time frame: Will be assessed from the beginning to the end of the test (50 seconds).
To analize muscle torque
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Fatigue
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Fernanda P Lima, Doctor principal investigator
Universidade do Vale do Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy in people with Fatigue and Stroke Sequelae, run by Universidade do Vale do Paraíba 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 20 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: status not confirmed, as of the sponsor's last update on 15 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela S Souza (5512997232806, gabrielasouza507@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain sensation (time frame: Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.