Gema León Physiotherapy and Rehabilitation Clinic
Córdoba, Andalusia, 14011, Spain
NCT Number: NCT06544395
The goal of this clinical trial is to demonstrate the effectiveness of non-invasive Neuromodulation as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19. It will also estimate the impact of non-invasive neuromodulation treatment on the functionality and quality of life of patients with COVID-19 sequelae.The main question it aim to answer is:
- Is non-invasive neuromodulation effective as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19.
Researchers will compare non-invasive neuromodulation to a placebo (treatment with the machine turned off).
Participants will:
* Be evaluated before starting treatment. * Be evaluated 3 weeks after. * Be evaluated at 5 weeks, or 15 sessions or completion of treatment. * Be evaluated 6 weeks after finishing the treatment or 11 weeks after starting treatment.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Córdoba, Andalusia, 14011, Spain
The waves of Sars-Cov-2 disease continue to be continuous and we are increasingly aware of the consequences it causes both in the respiratory system, musculoskeletal system and in the central and peripheral nervous system.
Likewise, non-invasive neuromodulation acts with a pump of ions, generating endogenous stimuli that modulate the central nervous system.
The aim of this clinical trial is to demonstrate the effectiveness of non-invasive Neuromodulation as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19.
To carry out this study, pain was measured with the visual analogue scale. It was also measured the joint amplitude, a muscle assessment with the help of a strength dynamometer, the patient's independence with the Katz index and the functionality of the lower or upper limbs, depending on the affected joint.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks.
Each intervention lasted 60 minutes. The intensity will be programmed in all sessions at Low, following the Arndt-Schulz law. The treatment was distributed in 3 phases: phase 1 of preparation, phase 2 to reduce fatigue and phase 3 to enhance autonomic improvement.
Common manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise.
In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks.
Each intervention lasted 60 minutes. The treatment was carried out with the machine turned off.
Time frame: one month
survey of patients about conditions diagnosed during the illness and those they suffer from after infection that are directly related to abnormalities to be assessed.
Time frame: one month
Nominal variables such as sex, age, vaccination and number of months with symptoms
Time frame: three months
Time frame: two months
Assess the quality of life impairments of patients with olfactory dysfunction. In a scale of 0 to 3, with higher scores reflecting better olfactory-specific
Time frame: two months
Assesses the impact of health on an individual's everyday life. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Time frame: two months
Assesses the ability to recognize familiar odors. A 12-item questionnaire. For each item, a microcapsule containing a familiar odor is scratched with a pencil and placed under the participant's nose.
The total score is the number of odors that are correctly recognized. Missing responses are assigned a partial score of 0.25. If more than 2 responses are missing, the entire test is treated as missing.
Time frame: two months
Quality of life related to health.
Questionaire with two parts:
Time frame: two months
It is used to evaluate functional impairment in people with upper extremity musculoskeletal dysfunction. 25 questions assessing the level of difficulty in performing activities of daily living using your upper extremities, including household and work activities, hobbies, lifting a bag of food, washing your scalp, pushing on your hands, driving, etc. Patients respond to each item by circling the number that best describes their level of difficulty.
Time frame: two months
Valid patient-rated outcome measure to measure lower extremity function. The lower the score the greater the disability. The minimal detectable change is 9 scale points.
Time frame: two months
Intensity of pain. Minimum value: 0 (absence of pain). Maximum value: 10 (unbearable pain). Optimal value: 0.
Time frame: two months
The sensory exam involves evaluation of pain and light touch. Test pain using a sharp object. At minimum, test the shoulders, arms and legs, comparing side to side and proximal to distal areas. In any area where the patient complains of sensory loss or hypersensitivity, more detailed testing may be required.
For light touch, uses your fingertips or a wisp of cotton, lightly stroke the skin and determine if the patient feels this symmetrically in all areas tested. At minimum, test the shoulders, arms and legs, comparing side to side and proximal to distal areas.
Time frame: two months
Respiratory evaluation. Minimum value: 0 (absence of dyspnea). Maximum value: 5 (dyspnea occurs with minimal efforts). Optimal value: 0.
Time frame: three months
measurement of lung function with spirometry and lung volume testing (measurement of maximum inspiratory and expiratory pressures (Pimax and Pemax, respectively)
Contact information is provided by the study sponsor or research team.
GEMA LEÓN BRAVO
CONTACT
GEMA LEÓN BRAVO
CONTACT
Clinica Gema Leon
Other
Efficacy of Non-invasive Neuromodulation Treatments for Post-COVID-19 Sequelae in Patients With Musculoskeletal, Respiratory and Neurological Conditions Due to Impaired Taste and Smell.
Acronym: COVID-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05638620
Autonomic Nervous System Diseases, Basal Ganglia Diseases
New York, United States
View Trial DetailsNCT06435403
COVID-19, COVID-19 Breakthrough
Addis Ababa, Ethiopia
View Trial DetailsNCT06168032
Antibody, COVID-19 Recurrent
Beijing, China
View Trial DetailsNCT07149428
Anosmia, Behavior
Bethesda, Maryland, United States
View Trial Details