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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03021252 |
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Date of registration:
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10/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Respiratory Muscle Training in Stroke Swallowing Disorders
RETORNUS-2 |
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Scientific title:
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The RETORNUS-2 Study: Impact of Respiratory Muscle Training on Swallowing Disorders in Stroke Patients |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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50 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03021252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Anna Guillén-Solà, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundació IMIM - Parc de Salut Mar |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- First-ever Ischemic or haemorrhagic stroke
- Time since stroke onset: 1 month
- Dysphagia confirmed by videofluoroscopic study with a score >3 in the 8-point
Penetration Aspiration Scale.
- Mini-mental State Exploration > 24)
Exclusion Criteria:
- Aphasia
- History of cardiopulmonary disease; neurologic condition other than stroke and
metabolic disease
- Medical treatment with potential effect on muscle structure and function
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Respiratory Muscle Training
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Swallowing Disorder
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Stroke
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Malnutrition
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Intervention(s)
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Device: High intensity IEMT
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Device: Sham IEMT
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Primary Outcome(s)
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Change in respiratory muscle strength
[Time Frame: Baseline and weekly during 8 weeks]
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Change in dysphagia severity
[Time Frame: Baseline, 8 weeks, 6 months post-stroke]
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Secondary Outcome(s)
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Change in fat-free mass
[Time Frame: Baseline, 3 months and 6 months post-stroke]
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Change in tongue strength
[Time Frame: Baseline and weekly during 8 weeks]
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Malnutrition at 6 months
[Time Frame: Baseline and 6 months post-stroke]
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Secondary ID(s)
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PSM/RHB/NR21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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