Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

Not Applicable

• Conditions: Stroke Rehabilitation

• 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.

Study Timeline

• Study First Submitted: 2018-12-17
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-08
• Last Update Submitted: 2019-01-08
• Study First Posted: 2019-01-11
• Last Update Posted: 2019-01-11
• Study Start: 2019-01-20
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-30

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

Primary Outcome Measures

Name	Time	Method
The "Berg balance scale" Test	From 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 pressure	From 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 second	From 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 capacity	From 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 )test	From 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.
Voluntary maximum ventilation	From 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

Secondary Outcome Measures

Name	Time	Method
Quadriceps dynamometry	From 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" Test	From 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 survey	From 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" Test	From 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