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Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

Not Applicable
Conditions
Stroke Rehabilitation
Interventions
Device: IMT
Registration Number
NCT03800485
Lead Sponsor
Hospital Universitario Virgen de la Arrixaca
Brief Summary

Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease

Detailed Description

Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease. The intervention will be done in a group of patients who will be treated in the rehabilitation service at the Virgen de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe device, to increase their inspiratory muscle strength in addition to a physical therapy treatment. The intervention will last eigtht weeks and the patients will be evaluated at the beginning and at the end of the intervention.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Sroke 6 months before of the beginning of the study
  • Be able to understand simple commands
  • Hemiparesis or hemiplegia
  • Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)
Exclusion Criteria
  • Associated neurological pathology leading to muscle weakness
  • Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,
  • intracranial hypertension
  • Acute retinal datachment, recent eye surgery
  • Impossibility of labial occlusion
  • Unstable heart disease, unstable angina, aortic aneurysm
  • Recent thoracic or abdominal surgery(6 months)
  • Uncontrolled arterial hypertension

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IMT-GEIMTthe participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure.
IMT-GPIMTThe participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks
Primary Outcome Measures
NameTimeMethod
Voluntary maximum ventilationFrom the first day of evaluation and at eight weeks of the beginning of the intervention

The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer

The "Berg balance scale" TestFrom the first day of evaluation and at Eight weeks of the beginning of the intervention

The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.

Maximum inspiratory pressureFrom the first day of evaluation and at eight weeks of the beginning of the intervention

The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks

Forzed espiratory volume in the first secondFrom the first day of evaluation and at eight weeks of the beginning of the intervention

The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer

Trunk control test (TCT)From the first day of evaluation and at Eight weeks of the beginning of the intervention

The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome

Forzed vital capacityFrom the first day of evaluation and at eight weeks of the beginning of the intervention

The change of the forzed vital capacity from the beginning and at the end of the intervention

The postural assessment scale for stroke patients (PASS )testFrom the first day of evaluation and at Eight weeks of the beginning of the intervention

The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.

Secondary Outcome Measures
NameTimeMethod
Quadriceps dynamometryFrom the first day of evaluation and at eight weeks of the beginning of the intervention

The change of the quadriceps´s strength with a hand held dynamometer at the beginning and in the end of the intervention. Higher values represents a better outcome

"Functional ambulatory classificator Hospital de Sagunto" TestFrom the first day of evaluation and at Eight weeks of the beginning of the intervention

The change of the walking capacity using the functional ambulatory classificator hospital de sagunto tool at the beginning and ni the end. The máximum value is 5 and the mínimum 0. Higher valúes represents better outcome

SF-36 health surveyFrom the first day of evaluation and at eight weeks of the beginning of the intervention

The change of the quality of life related to health with the SF-36 health survey at the beginning and in the end of the intervention

"Functional ambulatory classificator" TestFrom the first day of evaluation and at Eight weeks of the beginning of the intervention

The change of the walking capacity using the functional ambulatory classificator tool at the beginning and in the end of the intervention. The máximum value is 5 and the mínimum 0. Higher values represents a better outcome

Trial Locations

Locations (1)

Alicia Tovar Alcaraz

🇪🇸

Murcia, Spain

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