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Immediate Effect of Laser on Spasticity

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ClinicalTrials.gov Identifier: NCT02014935
Recruitment Status : Unknown
Verified December 2013 by Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora.
Recruitment status was:  Recruiting
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora

Brief Summary:

The poor eating habits and sedentary lifestyle of young people can reflect on structural changes in adult life, leading to vascular brain diseases. The cerebrovascular accident (AVC) represents the second cause of death throughout the country. Presents rapid development of clinical signs, providing focal disorders or brain function. It is necessary to the knowledge and development of new treatment techniques that may minimize the sequelae caused by the AVC, which is a common disease and of great impact on public health, represents the main cause of adult neurological disability, affecting the basic functions of the limbs, motor control and balance, strength and mobility, which involves changes in daily life and low self-esteemIn addition to the high cost of treatment and in the long run.

Thus, this study aims to analyze the response of low intensity laser on the prevention of pain and fatigue induced in rectus femoris, vastus of patients with sequelae of spasticity associated with effects on the laser promotes on muscle performance and muscle activity.

It is believed that this study get positive results as regards the increase of time antecedent to muscular fatigue associated with the skeletal muscle performance, so that the normotonics muscles gain strength and overcome the resistance of hypertonic muscles. In this way, it is expected that after the application of low intensity Laser Therapy (LILT) occurs to the adequacy of spasticity, muscle function the gain that had provided the highest quality of physiotherapy care.

It is known that treatment with the laser on the skeletal musculature, presents positive results and on the peak torque, by means of the skeletal muscle performance and consequently gain increase muscle performance (LEAL JUNIOR et al, 2010; ALMEIDA et al, 2011).

Armed with this information you can infer that the low intensity laser therapy on the spastic muscle, would result in improving muscle performance, with an increase of pre-stressing, improving the functional capacity of individuals under the exercises imposed by physical therapy. In this way, the sessions will take more satisfactory results which jointly provided better quality of life for these patients.


Condition or disease Intervention/treatment Phase
Ischemic Brain Other: Low intensity laser Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effect of Low Intensity Laser on the Spastic Muscle Fatigued.
Study Start Date : July 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Low intensity laser

So that this research recrutarou 30 subjects with spastic hemiparesis sequel, post stroke who have gone through three phases, with three evaluations. If this conformation is necessary, therefore, it is a search for intergroup analysis, and the values found in Phase I were faced with the values found in Phases II and III.

The phases comprise:

  • Phase I (1st Cycle): Individuals treated with LLLT not only performed the evaluation of muscle activity, torque and lactic acid level.
  • Phase II (2nd Cycle): Individuals undergoing the application of LLLT, with the same off, and assessment of muscle activity, torque and lactic acid level.
  • Phase III (3rd Cycle): Individuals undergoing the application of LILT and evaluation of muscle activity, torque and lactic acid level.
Other: Low intensity laser

The study wants to evaluate the use of low intensity laser on the spastic muscle.

Want to assess whether the Low level laser prove change in muscle performace of the individual but also alters muscle activity and blood lactate.





Primary Outcome Measures :
  1. muscle activity [ Time Frame: three days ]
    Muscle activity will be captured with the aid of electromyography. So that the EMG data will be collected with the completion of the isometric contraction of the rectus femoris, vastus. Being held in this capture period of 50 seconds.


Secondary Outcome Measures :
  1. muscular performance [ Time Frame: three days ]

    The muscular performance will be analyzed with the equipment isokinetic dynamometer.

    Volunteers will be placed in a sitting position in the chair equipment (Biodex System ®), with the limb to be assessed on the supported equipment support.

    Thus the device is triggered mode isometric contraction and the individual remained in contraction for a time of 50 seconds. Patients will be advised to carry their maximum contraction so as to obtain the torque of the muscles.



Other Outcome Measures:
  1. blood lactate [ Time Frame: three days ]
    The collection of blood lactate happen with the aid of lactomer , portable device brand (Accutrend ® PLUS Roche). Will be collected before and after the completion of the exercise isometric contraction, a drop of blood to detect the level of lactate in the blood. So to differentiate the amount found in the blood before and after exercise and to see whether the application of Laser alter this concentration in the blood.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People with spastic hemiparesis;

    • Medical referral for physiotherapy;
    • Age between 40 and 80 years;
    • Women who are in menopause;
    • Cognitive preserved, being able to respond to verbal stimuli;
    • Modified Ashworth scale, with a maximum of 2 degree of spasticity in the flexor muscles of the knee, specifically in the muscles that make up the Quadriceps femoris.

Exclusion Criteria:

  • · Patients with Hypoesthesia and/or Hyperesthesia of the side to be studied

    • The presence of active infection and rashes at the site of application of the electrodes;
    • Joint stiffness, contractures and deformities;
    • Broca's aphasia
    • Uncontrolled arterial hypertension;
    • Presence of neoplastic lesion at the site of application;
    • Intake of analgesics and/or anti-inflammatory medication during the two weeks of evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014935


Contacts
Contact: Mariana C Reis, Therapy 1288291319 mah.crr@gmail.com

Locations
Brazil
Universidade do Vale do Paraíba Recruiting
São José dos Campos, São Paulo, Brazil, 12244000
Contact: Mariana C Reis, Therapist    1288291319    mah.crr@gmail.com   
Contact: Djenifer Q Souza, Therapist    1282471972      
Sub-Investigator: Djenifer Q Souza, Therapist         
Sponsors and Collaborators
Laboratório de Engenharia de Reabilitação Sensorio Motora
Investigators
Principal Investigator: Mariana C Reis, Therapy University of Vale do Paraiba

Additional Information:
Publications:
ALMEIDA, P., et al. Red (660nm) and infrared (830nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better?. Lasers in a Medical Science., v.27, p.453-458, 2012. LEAL JUNIOR, E. C., et al. Effects of low level laser therapy (LLLT) in the development of exercise-induced skeletal muscle fatigue and changes in biochemical markers related to post- exercise recovery. Journal of Orthopaedic & Sports Physical Therapy., v.40, n.8, p.524-32, 2010. DIETZ, V.; SINKJAER, T. Spastic movement disorder:impaired reflex function and altered muscle mechanics Review. Lancet Neurology., v.6, p.725-733, 2007. MINISTÉRIO DA SAÚDE SÃO PAULO: banco de dados. Disponível em: http://portalsaude.saude.gov.br/portalsaude/noticia/7904/162/avc:-governo-alerta-para-%3Cbr%3Eprincipal-causa-de-mortes.html. STROKE, 2006. In:World Health Organization. Neurological disordes: public health challenges. Geneva: World Health Organization, 2006. p.163-175.

Responsible Party: Djenifer Queiroz de Souza, Mariana César Ribeiro dos Reis, Laboratório de Engenharia de Reabilitação Sensorio Motora
ClinicalTrials.gov Identifier: NCT02014935     History of Changes
Other Study ID Numbers: CAAE 1542193200005503
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora:
Low-intensity Laser
Spasticity
pain,
Fatigue