- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473612
Physical Status and Upper Airway Function in Neuromuscular Patients
Degree Physical Status and Upper Airway Function in Neuromuscular Patients
Inside of studies that report an upper airway function impaired, the upper limb strength has been demonstrated to be determinant in breath, speech and swallow performance. Nevertheless, no previous studies in neuromuscular disease have explored the relation between general disability and upper airway function.
There is a suspicion of upper airway which is associated with physical deterioration, however the extent to which if feeds back has not been explored.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Granada, Spain
- University of Granada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of Neuromuscular disease
- Between 6 and 65 years
- Impairment of the upper airway
- Accepted to sign the informed consent
Exclusion Criteria:
- Cognitive impairment.
- Diagnose of autism spectrum disorder or severe intellectual disability
- Physical or functional impairment that limits the performance of evaluation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control group
Healthy subjects
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Neuromuscular low physical status group
Patients diagnosed of Neuromuscular disease with low physical status
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Neuromuscular high physical status group
Patients diagnosed of Neuromuscular disease with high physical status
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hand grip strength
Time Frame: Baseline
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Hand grip strength will be evaluated with a pressure dynamometer according to the protocol, to their maximum ability in a seated position . The average of three attempts for the dominant hand will be recorded. It has been proven that it can be used as an indicator of general health and as a strong predictor of future mortality, disability, falls, complications and resource utilization. |
Baseline
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Respiratory function
Time Frame: Baseline
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Respiratory function will be evaluated with spirometry following standardized protocols.
Collected variables will be Forced Expiratory Volume in the First Second (FEV1), Forced Vital Capacity (FVC) and Maximal Voluntary Ventilation (MVV).
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Baseline
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Peak expiratory flow
Time Frame: Baseline
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Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air.
It will be measured following standardized protocols.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hospital Anxiety and Depression Scale
Time Frame: Baseline
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Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS) .
This scale is composed of 14 items divided into two subscales, 7 items of anxiety and 7 items of depression, involving higher values worse psycho-emotional state.
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Baseline
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European Quality of Life-5 Dimensions (EQ-5D)
Time Frame: Baseline
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The perception of the level of health and the quality of life were evaluated with the questionnaire European Quality of Life-5 Dimensions (EQ-5D). It is composed of 2 parts in which health status is assessed:
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Baseline
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Fatigue Severity Scale
Time Frame: Baseline
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Fatigue severity scale (FSS) will be used to measure fatigue.
It consists of 9 items with answers that the patient scores between 1 and 7.
The total is calculated by adding all the items.
For children will be used The PedsQL™ Multidimensional Fatigue Scale, which is composed of 18 items comprising 3 dimensions (general fatigue, sleep/rest fatigue, cognitive fatigue), evaluated thorough a Liker scale with values from 0 (never) to 4 (almost always), referring to difficulty presented.
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Baseline
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World Health Organization Disability Assessment Scale (WHODAS) 2.0 (WD2)
Time Frame: Baseline
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To measure the degree of disability, the World Health Organization Disability Assessment Scale, WHODAS 2.0 (WD2) will be used.
It measures changes in functioning and levels of difficulty in carrying out and carrying out its activities .
The WD2 scale is composed of 36 items divided into 6 domains, evaluated through a Likert scale with values from 1 to 5, referring to the difficulty presented.
Higher scores show a greater degree of disability.
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Baseline
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Activity Limitations in Children and Adults With Neuromuscular Disorders (ACTIVLIM)
Time Frame: Baseline
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The Activity Limitations in Children and Adults With Neuromuscular Disorders (ACTIVLIM) questionnaire is an instrument to measure functional limitation and has been calibrated in children and adults with neuromuscular diseases, according to the difficulty of patients to perform daily activities that require the use of the upper extremities and / or lower.
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Baseline
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Brief pain inventory
Time Frame: Baseline
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For pain assessment we will use a specific brief pain questionnaire, Brief Pain Inventory , which consists of three parts.
In the first, the patient will indicate in a drawing the area in which he presents this pain.
The second part refers to the pain felt in the last days, where it is scored, as in the previous questionnaire, from 0 to 10 (0 being no pain and 10 being the maximum pain felt).
Finally, in a third part we see how that pain influences the different activities that the patient performs in his day to day.
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Baseline
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Muscle strength of the neck
Time Frame: Baseline
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To evaluate the muscle strength of the neck in neuromuscular patients, neck dynamometry will be performed.
With subtests in which front bending, extension, pure lateral flexion, lateral flexion with rotation and pure rotation were measures.
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Baseline
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Eating Assessment Tool-10 (EAT-10)
Time Frame: Baseline
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The EAT-10 is a self-administered instrument that evaluate specific symptoms of dysphagia with 10 items and each item have a range from zero (no problem to swallow) to four (a serious problem for life). In the case of patients pediatric with dysphagia it used Pediatric Eating Assessment Tool (PEDI-EAT-10) |
Baseline
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Swallowing quality of life questionnaire (SWAL-QOL)
Time Frame: Baseline
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To measure the possible swallowing problems in daily life we will used the SWAL-QOL, it contains 44 items and each item was scored from zero (the worst state) to four (the best state) .
This questionnaire consists of 44 items, consisting of 11 subscales.
With a Likert type score in which the patient scores between 1 and 5.
Where 1 indicates the worst state and 5 the most favorable.
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Baseline
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Functional Oral Intake Scale (FOIS) questionnaire
Time Frame: Baseline
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The severity of swallowing will be assessed using the Functional Oral Intake Scale (FOIS) questionnaire .
This scale consists of 7 levels, with 1 being the most severe and 7 being the least severe, the patient has to select the level with which he is.
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Baseline
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Karaduman Chewing Performance Scale (KCPS)
Time Frame: Baseline
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There are also questionnaires like Karaduman Chewing Performance Scale (KCPS) , that permitted us evaluate the function of chewing, this test has not been used in previous studies in adults, so in this study we have only used it in the childrens patients.
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Baseline
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Orofacial Myofunctional Evaluation with Scores (OMES)
Time Frame: Baseline
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Clinical evaluation of the orofacial myofunctional condition will be evaluated using the Orofacial Myofunctional Evaluation with Scores (OMES) .
It consisting of 4 subscales: appearance and posture, mobility and functions (breathing, deglutition, mastication).
The examiner attributed scores on a 3 point scale: 3=normal, 2= insufficient ability; and 1= absence of ability or being unable to perform the task.
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Baseline
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Volume Viscosity Clinical Exploration Method (MECV-V)
Time Frame: Baseline
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Volume Viscosity Clinical Exploration Method (MECV-V) , this test provides us with information about the volume to which the 5ml, 10ml and 20 ml patients are able to feed and tells us what viscosity, nectar, liquid and pudding.
It is used in the diagnosis of oropharyngeal dysphagia.
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Baseline
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Voice handicap index (VHI-30)
Time Frame: Baseline
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The phonatory function and it´s repercussion on daily life will be evaluated by the Voice handicap index (VHI-30) .
This scale consists of 30 items, consisting of 3 subscales, functional, physical and emotional.
In which the patient must indicate the presence or symptoms of dysphonia with a Likert type score of 5 points, in which 0 indicates never and 4 always indicates.
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Baseline
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Grade, Roughness, Breathing, Asthenia, Effort (GRBAS)
Time Frame: Baseline
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Perceptual scale of Grade, Roughness, Breathing, Asthenia, Effort (GRBAS) .
Will be used to analyze qualitative aspects of the voice, it is completed by the evaluator who qualifies as: 0 normal, 1 mild, 2 moderate, 3 severe, each quality of the voice (Degree of dysphonia, scratchy, blown, weak or asthenic, tight or strangled).
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Baseline
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Functional evaluation of the voice
Time Frame: Baseline
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The functional evaluation of the voice will allow us to measure the intensity, frequency and duration of the voice: To evaluate the intensity of the voice, measured in decibels (dB), we will use a sound level meter; To evaluate the frequency of the voice , measured in Hz (Hz), we use the PRAAT software (Praat from the Dutch "speak").
In addition, the duration of the phonation and breathing times , measured in Sg, will be evaluated, for this we use an audio recorder.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0091UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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