Ischemic BrainNCT02014935
Immediate Effect of Laser on Spasticity
A study testing Low intensity laser in people with Ischemic Brain, run by Laboratório de Engenharia de Reabilitação Sensorio Motora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Brain
- What is being tested?
- Low intensity laser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Feb 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- · 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Vale do Paraíba
São José dos Campos, São Paulo, 12244000
Mariana C Reis, Therapist, 1288291319, mah.crr@gmail.com
Djenifer Q Souza, Therapist, 1282471972
About this study
Official title: Immediate Effect of Low Intensity Laser on the Spastic Muscle Fatigued.
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.
Read more
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.
Read the detailed description
With the course of the years, became notorious the transformation in the epidemiological profile of the Brazilian population, with the progressive decline of infectious diseases and illness narratives and the gradual growth of the chronic degenerative diseases, particularly cardiovascular diseases of (ARAÚJO, 2012)
According to statistics of the Ministry of health, in the year 2010 were recorded about 100 thousand deaths due to cerebrovascular accident (AVE), a result of the sudden interruption of blood flow of the brain, which is currently responsible for leading cause death in Brazil (MINISTRY of health, 2012).
The heterogeneity of the Brazilian population, would explain the current epidemiological transition, and as a result the high rates of mortality. The diseases of the circulatory system are as main cause death of Brazil, emphasizing the cerebrovascular disease, responsible for one third of deaths in the country.
The cerebral arteries are responsible for giving the necessary nutrients as a source of energy to neurons, the brain requires intense blood flow to meet your high intake of nutrients. Being that the interruption of the flow of oxygen and glucose for a period in excess of five minutes can cause irreversible damage to the brain.
Several pathological processes can cause the interruption of blood flow in certain brain areas. Between these processes include hemorrhages, embolisms, stroke and diseases that lead to suspension of blood flow, and therefore the deficit in the supply of nutrients.
The blood deficit promotes changes in cellular metabolism, which can lead to injury and/or death of brain tissue. According to estimates, 80% of the incidence of BIRD arteriolar occlusion resulting from atheroma plates or secondary brain artery emboli that deprive the brain of blood supply.
The likelihood of the AVE doubles every decade of life, from 55 years of age. Although leverage the ranking of deaths in the country, statistics from the Ministry of health in 2010, showed decreased mortality rate in the age group up to 70 years, representing an annual average reduction of 3.2% (MINISTRY of health, 2012).
As established earlier, the differences in the prevalence of risk factors among the population due to high heterogeneity, that is, different customs, habits and lifestyles. So in that, poor eating habits and physical youth population may reflect structural changes in adulthood, and may lead to vascular brain diseases. Among the risk factors associated with the AVE is hypertension, dyslipidemias, diabetes, smoking, alcoholism.
In general the clinical picture presents itself with motor and sensory changes, that may be associated with deficits in cognitive and perceptual functions by damaging both physical and physiological functions of the patient (DIETZ; SINKJAER, 2007). Due to the AVE be associated with motor disability tables, resulting in physical limitations, mainly resulting from spasticity, is necessary to search for ways to minimise this damage. In this way, it is believed that with the help of biomedical instrumentation, which in addition to providing quantitative and reliable data on the functional capacity of the individual, allows the development and recruitment of equipment to help in the evaluation of the General State of the patient and so consequently best results before the practice of neurological rehabilitation. Therefore it is of utmost importance to biomedical resource utilization as surface electromyography that refers to a method of non-invasive monitoring, providing values for the square root of the mean squared Value (RMS - R Englishoot Mean Square), demonstrating this parameter the results of signal amplitude through the average power in the time interval analyzed, containing information about the amount of traction units fired at any given movement
Isokinetic dynamometry bound that provides resistance to joint movement over a given range, enabling the analysis of muscle force-related parameters such as torque, power, and endurance. These two features combined will contribute to the determination of the time when the o muscle spastics had to fatigue muscles. On this information, the sessions can be reworded to the concrete limitations of patients and consequently the improvement of rehabilitation, which will automatically improves the quality of life of these individuals.
- Conditions
- Ischemic Brain
- Being tested
- Low intensity laser
- Keywords
- Low-intensity Laser, Spasticity, pain,, Fatigue
- Medical subject headings
- Muscle Spasticity, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity laserOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Low intensity laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three days
Secondary outcomes (1)
muscular performance
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.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic BrainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório de Engenharia de Reabilitação Sensorio Motora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora
- Investigators
- Mariana C Reis, Therapy, Principal investigator, University of Vale do Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014935
- Sponsor's protocol ID
- CAAE 1542193200005503
- Status last verified
- Dec 2013
- First submitted
- 7 Nov 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Low Intensity Laser on the Spastic Muscle Fatigued.
- ClinicalTrials.gov ID
- NCT02014935
- Acronym / sponsor ID
- CAAE 1542193200005503
- Conditions
- Ischemic Brain
- Keywords
- Low-intensity Laser, Spasticity, pain,, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laboratório de Engenharia de Reabilitação Sensorio MotoraUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- 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.
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.
Detailed description
With the course of the years, became notorious the transformation in the epidemiological profile of the Brazilian population, with the progressive decline of infectious diseases and illness narratives and the gradual growth of the chronic degenerative diseases, particularly cardiovascular diseases of (ARAÚJO, 2012)
According to statistics of the Ministry of health, in the year 2010 were recorded about 100 thousand deaths due to cerebrovascular accident (AVE), a result of the sudden interruption of blood flow of the brain, which is currently responsible for leading cause death in Brazil (MINISTRY of health, 2012).
The heterogeneity of the Brazilian population, would explain the current epidemiological transition, and as a result the high rates of mortality. The diseases of the circulatory system are as main cause death of Brazil, emphasizing the cerebrovascular disease, responsible for one third of deaths in the country.
The cerebral arteries are responsible for giving the necessary nutrients as a source of energy to neurons, the brain requires intense blood flow to meet your high intake of nutrients. Being that the interruption of the flow of oxygen and glucose for a period in excess of five minutes can cause irreversible damage to the brain.
Several pathological processes can cause the interruption of blood flow in certain brain areas. Between these processes include hemorrhages, embolisms, stroke and diseases that lead to suspension of blood flow, and therefore the deficit in the supply of nutrients.
The blood deficit promotes changes in cellular metabolism, which can lead to injury and/or death of brain tissue. According to estimates, 80% of the incidence of BIRD arteriolar occlusion resulting from atheroma plates or secondary brain artery emboli that deprive the brain of blood supply.
The likelihood of the AVE doubles every decade of life, from 55 years of age. Although leverage the ranking of deaths in the country, statistics from the Ministry of health in 2010, showed decreased mortality rate in the age group up to 70 years, representing an annual average reduction of 3.2% (MINISTRY of health, 2012).
As established earlier, the differences in the prevalence of risk factors among the population due to high heterogeneity, that is, different customs, habits and lifestyles. So in that, poor eating habits and physical youth population may reflect structural changes in adulthood, and may lead to vascular brain diseases. Among the risk factors associated with the AVE is hypertension, dyslipidemias, diabetes, smoking, alcoholism.
In general the clinical picture presents itself with motor and sensory changes, that may be associated with deficits in cognitive and perceptual functions by damaging both physical and physiological functions of the patient (DIETZ; SINKJAER, 2007). Due to the AVE be associated with motor disability tables, resulting in physical limitations, mainly resulting from spasticity, is necessary to search for ways to minimise this damage. In this way, it is believed that with the help of biomedical instrumentation, which in addition to providing quantitative and reliable data on the functional capacity of the individual, allows the development and recruitment of equipment to help in the evaluation of the General State of the patient and so consequently best results before the practice of neurological rehabilitation. Therefore it is of utmost importance to biomedical resource utilization as surface electromyography that refers to a method of non-invasive monitoring, providing values for the square root of the mean squared Value (RMS - R Englishoot Mean Square), demonstrating this parameter the results of signal amplitude through the average power in the time interval analyzed, containing information about the amount of traction units fired at any given movement
Isokinetic dynamometry bound that provides resistance to joint movement over a given range, enabling the analysis of muscle force-related parameters such as torque, power, and endurance. These two features combined will contribute to the determination of the time when the o muscle spastics had to fatigue muscles. On this information, the sessions can be reworded to the concrete limitations of patients and consequently the improvement of rehabilitation, which will automatically improves the quality of life of these individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low intensity laser | Experimental | Other: Low intensity laserSo 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People with spastic hemiparesis;
Key exclusion criteria (7 listed)
- · Patients with Hypoesthesia and/or Hyperesthesia of the side to be studied
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 intensity laserThe 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. | Other | Low intensity laser |
Primary outcome
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.
1 secondary outcome
muscular performance
Time frame: three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- BackgroundALMEIDA, 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.
- This study serves as a reference of the protocol being carried out.Link provided by the sponsor.
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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.
Mariana C Reis, Therapy principal investigator
University of Vale do Paraiba
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 intensity laser in people with Ischemic Brain, run by Laboratório de Engenharia de Reabilitação Sensorio Motora 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 6 inclusion and 7 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 19 Dec 2013. 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 Mariana C Reis, Therapy (1288291319, mah.crr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle activity (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014935, which also lists 1 linked publication.
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 19 Dec 2013.