NCT02014935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

November 7, 2013

Last Update Submit

December 18, 2013

Conditions

Keywords

Low-intensity LaserSpasticitypain,Fatigue

Outcome Measures

Primary Outcomes (1)

  • muscle activity

    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.

    three days

Secondary Outcomes (1)

  • muscular performance

    three days

Other Outcomes (1)

  • blood lactate

    three days

Study Arms (1)

Low intensity laser

EXPERIMENTAL

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

Interventions

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.

Low intensity laser

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • · 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade do Vale do Paraíba

São José dos Campos, São Paulo, 12244000, Brazil

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Muscle SpasticityPainFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mariana C Reis, Therapy

    University of Vale do Paraiba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana C Reis, Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mariana César Ribeiro dos Reis

Study Record Dates

First Submitted

November 7, 2013

First Posted

December 19, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations