Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals

NCT03753984 | Unknown

• 1 other identifier: UNIVAP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Stroke Sequelae

Keywords

Fatigue; Low-level Laser Therapy; Stroke; Infrared thermograpy

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  Baseline (before test) and after the test (3, 15 and 25 minutes after the test)

• Isokinetic dynamometer

  To analize muscle torque

  Will be assessed from the beginning to the end of the test (50 seconds).

Study Arms (2)

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).

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).

Other: Low-level laser therapy

Interventions

Low-level laser therapy OTHER

In both arms will be applied Low-level laser therapy and induced muscle fatigue.

Healthy group; Post stroke group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Universidade do Vale do Paraíba: lead

Study Sites (1)

Universidade do Vale do Paraiba

São José dos Campos, São Paulo, 12.244-000, Brazil

RECRUITING

MeSH Terms

Conditions

Fatigue; Stroke

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Fernanda P Lima, Doctor

  Universidade do Vale do Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela S Souza

CONTACT

5512997232806; gabrielasouza507@yahoo.com.br

Gabriela S Souza

CONTACT

5512997232806; fpupio@univap.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 27, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2020
• Last Updated: July 15, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)