Back to resultsEffects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals
Primary Purpose
Fatigue, Stroke Sequelae
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low-level laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Low-level Laser Therapy, Stroke, Infrared thermograpy
Eligibility Criteria
Inclusion Criteria (Healthy group):
- 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.
Inclusion Criteria (Post stroke group):
- 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.
Exclusion Criteria (Healthy group):
- 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;
- 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.
Exclusion Criteria (Healthy group):
- 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.
Sites / Locations
- Universidade do Vale do ParaibaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy group
Post stroke group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
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.
Analyze the behavior of the local temperature (Infra-red thermography)
To analize the local temperature.
To evaluate changes in lactate concentration through lactimeter.
A collection of blood lactate levels will be performed at four different times.
Isokinetic dynamometer
To analize muscle torque
Secondary Outcome Measures
Full Information
NCT ID
NCT03753984
First Posted
October 31, 2018
Last Updated
July 12, 2019
Sponsor
Universidade do Vale do Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT03753984
Brief Title
Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Vale do Paraíba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Stroke Sequelae
Keywords
Fatigue, Low-level Laser Therapy, Stroke, Infrared thermograpy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy group
Arm Type
Experimental
Arm Description
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).
Arm Title
Post stroke group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Low-level laser therapy
Intervention Description
In both arms will be applied Low-level laser therapy and induced muscle fatigue.
Primary Outcome Measure Information:
Title
Changes in pain sensation
Description
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.
Time Frame
Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
Title
Surface electromyograph
Description
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.
Time Frame
Will be assessed from the beginning to the end of the test (50 seconds).
Title
Analyze the behavior of the local temperature (Infra-red thermography)
Description
To analize the local temperature.
Time Frame
Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
Title
To evaluate changes in lactate concentration through lactimeter.
Description
A collection of blood lactate levels will be performed at four different times.
Time Frame
Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
Title
Isokinetic dynamometer
Description
To analize muscle torque
Time Frame
Will be assessed from the beginning to the end of the test (50 seconds).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Healthy group):
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.
Inclusion Criteria (Post stroke group):
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.
Exclusion Criteria (Healthy group):
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;
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.
Exclusion Criteria (Healthy group):
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela S Souza
Phone
5512997232806
Email
gabrielasouza507@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela S Souza
Phone
5512997232806
Email
fpupio@univap.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda P Lima, Doctor
Organizational Affiliation
Universidade do Vale do Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade do Vale do Paraiba
City
São José Dos Campos
State/Province
São Paulo
ZIP/Postal Code
12.244-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela S Souza
Phone
5512997232806
Email
gabrielasouza507@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals
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