Multiple Sclerosis Clinical Trial
Official title:
Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 24, 2020 |
Est. primary completion date | December 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Healthy Sciences | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trunk motor control | 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. | baseline | |
Primary | Swallowing function | To evaluate swallowing function we used two questionnaires: the Swallowing quality of life questionnaire (SWAL-QOL). It contains 44 items and each item was scored from zero (the worst state) to four (the best state). | baseline | |
Primary | Swallowing function | 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. | baseline | |
Primary | Ventilation function | Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy). | baseline | |
Primary | Phonation function | The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30), | baseline | |
Primary | The exercise capacity focussed on lower limbs | The Five-Times-Sit-to-Stand test (5STS) | baseline | |
Primary | The exercise capacity focussed on upper limbs | The exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX) | baseline | |
Primary | The anaerobic threshold | Incremental sit-to-stand test (ISTS) | baseline | |
Secondary | Psychological status | Psychological status was evaluated with and the Beck Depression Inventory (Beck) to measure depression. The values range to 0 from 63, being higher values, most severe depression. | baseline | |
Secondary | Psychological status | Psychological status was evaluated with the Beck Anxiety Inventory (BAI) to measure anxiety. The values range to 0 from 63, being higher values, most severe anxiety. | baseline | |
Secondary | The degree of neurological functioning | The degree of neurological functioning in patients with MS was measured with the Kurtzke Expanded Disability Status Scale (EDSS). The values range to 0 from 10, being 0 normal status healthy and 10 the death. | baseline | |
Secondary | The impact of the multiple sclerosis disease | The impact of the disease was determinate with the Multiple Sclerosis Impact Scale (MSIS-29). It´s an instrument with 20 physical items and 9 psychological items. |
baseline |
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