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Clinical Trials/NCT04473612
NCT04473612
Completed
Not Applicable

Degree Physical Status and Upper Airway Function in Neuromuscular Patients

Universidad de Granada1 site in 1 country41 target enrollmentJuly 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Diseases
Sponsor
Universidad de Granada
Enrollment
41
Locations
1
Primary Endpoint
Hand grip strength
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2020
End Date
September 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Principal Investigator; PT; PhD

Universidad de Granada

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hand grip strength

Time Frame: Baseline

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.

Respiratory function

Time Frame: Baseline

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).

Peak expiratory flow

Time Frame: Baseline

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.

Secondary Outcomes

  • Muscle strength of the neck(Baseline)
  • Eating Assessment Tool-10 (EAT-10)(Baseline)
  • Swallowing quality of life questionnaire (SWAL-QOL)(Baseline)
  • Functional Oral Intake Scale (FOIS) questionnaire(Baseline)
  • Karaduman Chewing Performance Scale (KCPS)(Baseline)
  • Orofacial Myofunctional Evaluation with Scores (OMES)(Baseline)
  • Volume Viscosity Clinical Exploration Method (MECV-V)(Baseline)
  • European Quality of Life-5 Dimensions (EQ-5D)(Baseline)
  • Fatigue Severity Scale(Baseline)
  • World Health Organization Disability Assessment Scale (WHODAS) 2.0 (WD2)(Baseline)
  • Activity Limitations in Children and Adults With Neuromuscular Disorders (ACTIVLIM)(Baseline)
  • Brief pain inventory(Baseline)
  • Hospital Anxiety and Depression Scale(Baseline)
  • Voice handicap index (VHI-30)(Baseline)
  • Grade, Roughness, Breathing, Asthenia, Effort (GRBAS)(Baseline)
  • Functional evaluation of the voice(Baseline)

Study Sites (1)

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