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Clinical Trials/NCT04252599
NCT04252599
Unknown
Not Applicable

Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.

Universidad de Granada1 site in 1 country60 target enrollmentNovember 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Universidad de Granada
Enrollment
60
Locations
1
Primary Endpoint
Phonation function
Last Updated
6 years ago

Overview

Brief Summary

Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Different areas are affected, including upper airway function, trunk motor control and cardiorespiratory performance. The aim of this study was to determinate the relevance of trunk motor control in upper airway function and cardiorespiratory performance in patients with multiple sclerosis.

Registry
clinicaltrials.gov
Start Date
November 20, 2019
End Date
January 24, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

assistant professor

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Have a diagnosis of MS in any of its forms according to McDonald criteria
  • Were aged higher than 18 years
  • No pathology in the uppers extremities
  • Capacity to understand and response the questionnaires
  • Ability to provide informed consent.

Exclusion Criteria

  • Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
  • Inability to provide informed consent.

Outcomes

Primary Outcomes

Phonation function

Time Frame: baseline

The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),

Swallowing function

Time Frame: baseline

To evaluate swallowing function we used two questionnaires: the Eating Assessment Tool-10 (EAT-10). The values range from 0 to 4 being higher values worse swallowing function.

Ventilation function

Time Frame: baseline

Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).

The exercise capacity focussed on lower limbs

Time Frame: baseline

The Five-Times-Sit-to-Stand test (5STS)

The exercise capacity focussed on upper limbs

Time Frame: baseline

The exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX)

The anaerobic threshold

Time Frame: baseline

Incremental sit-to-stand test (ISTS)

Trunk motor control

Time Frame: baseline

The impairment of trunk motor control was measured with the Modified Trunk Impairment Scale (mTIS). The values range to 0 from 16 being higher values, better trunk motor control.

Secondary Outcomes

  • The impact of the multiple sclerosis disease(baseline)
  • Psychological status(baseline)
  • The degree of neurological functioning(baseline)

Study Sites (1)

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