Sensory-motor and cardiorespiratory sensory rehabilitation associated with transcranial photobiomodulation in patients with central nervous system injury: Trial protocol for a single-center, randomized, double-blind, and controlled clinical trial.
Medicine (Baltimore)
; 98(25): e15851, 2019 Jun.
Article
en En
| MEDLINE
| ID: mdl-31232920
ABSTRACT
BACKGROUND:
Central nervous system diseases such as stroke, spinal cord injury, traumatic brain injury, and multiple sclerosis can be fatal or cause sequelae, affecting sensorimotor and cardiorespiratory systems and quality of life. These subjects present a low response to aerobic and resistance exercise, due to decreased recruitment of muscle fibers and reduction of metabolic capacity. Aerobic exercises bring benefits in terms of fatigue retardation, gait improvement, regulation of the autonomic nervous system, neuroprotection of the brain, stimulation of the production of endogenous neutrotransmitters related to general well-being, and a favoring of neuroplasticity. Photobiomodulation (PBM Therapy) (previously known as low-level laser therapy), and especially transcranial PBM Therapy, has shown benefits in animals and humans such as cognitive improvement, memory, and behavioral improvement, including attenuation of depression and anxiety, and increased cortical oxygenation. The aims of this trial will be to evaluate the parameters related to the function of the musculoskeletal and cardiorespiratory system and the impact of PBM therapy on these parameters, as part of a rehabilitation and training program for people with reduced mobility.METHODS:
This is a randomized, double-blind, placebo-controlled trial with 3 groups Control, only cardiorespiratory rehabilitation (CCR), CCR with PBM Therapy (CR-PBM), CCR and placebo PBM Therapy (CR-PlaceboPBM). nâ=â90, 30 per group. PBM Therapy parameters 810ânm laser, 0.028âcm, 100âmW, 3.5âW/cm, 30âseconds per point, 3âJ per point, 107.1âJ /cm to 3 electroencephalogram points F7 and F8 and AFz. The trial will be conducted at the University Clinics and the sessions will be 1âhour twice a week for 9 weeks. Baseline, intermediate (4th week), final (9th week), and 2-month follow-up will be performed. Muscular activation, heart rate variability, lung volumes and capacities, fatigability, exercise tolerance, cognition, and quality of life at baseline will be evaluated. Subsequent to baseline evaluations, the PBM Therapy groups will be offered laser therapy (active or inactive); all groups will then receive CCR. TRIAL REGISTRATION NUMBER ClinicalTrials.gov ID - NCT03751306 (approval date November 22, 2018).
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Traumatismos de la Médula Espinal
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Terapia por Luz de Baja Intensidad
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Lesiones Traumáticas del Encéfalo
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Esclerosis Múltiple
Tipo de estudio:
Clinical_trials
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Guideline
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Risk_factors_studies
Idioma:
En
Revista:
Medicine (Baltimore)
Año:
2019
Tipo del documento:
Article