Clinical trial NCT02473432: Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke
Official title: Neuromuscular Electroestimulation and Respiratory Muscle Training in the Management of Dysphagia of Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysphagia
Keywords: respiratory muscle training
neuromuscular electrical stimulation
oropharyngeal dysphagia
stroke
rehabilitation
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study, part of a larger research project (The Retornus Study), is aimed to evaluate new strategies to optimize rehabilitation outcomes in dysphagic stroke patients. Main objective is to assess effectiveness of neuromuscular electroestimulation (NMES) in combination with respiratory muscle training (RMT) in the treatment of oropharyngeal dysphagia in subacute stroke patients.

Detailed description: Dysphagia is present in a significant proportion of subacute stroke patients (up to 85%, depending on the series) and is associated with an increase in medical complications such as bronchoaspirative pneumoniae which is responsible for approximately half of the deaths that occur in these patients. Besides, the risk of pneumonia in patients with dysphagia is three times higher compared to those patients without. Since there is no drug able to restore the swallowing and respiratory muscle function, neurological rehabilitation apperars to be as the mainstay of treatment of these disorders.

Respiratory muscle weakness is common after stroke, but how it contributes in the development of bronchoaspiration pneumonia is not well determined. In acute phases of stroke, the mechanism seems to be more related to an impaired central drive than the reduction of strength in respiratory muscle.

Otherwise, the NMES aims to improve muscle strength. The NMES accelerates swallowing recovery since it induces brain reorganitzation after stroke through sensory and motor stimulation of peripheral nerves, mainly in swallowing aerea.

Eligibility criteria: Inclusion Criteria:

* First-ever ischemic stroke
* Time since stroke onset: 1 to 3 weeks
* Tracheobronchial aspiration evaluated with the gold standard, videofluoroscopy,
* Cognitive impairment (Short Portable Mental Status Questionnaire less than 3)

Exclusion Criteria:

* Previous history of neurological diseases that might be associated with the presence of dysphagia
* Previous history of pulmonary diseases
* Significant alcohol abuse (\>80 g/day) and 4) medical treatment with potential effect on muscle structure and function (steroids,thyroid hormones, immunosuppressors).

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: up to 3 months follow-up
Secondary outcomes:
measure: Maximal inspiratory and expiratory muscle strength
timeFrame: up to 3 months follow-up
measure: Security of swallowing oral phase
timeFrame: up to 3 months follow-up
measure: Number of participants with signs of impaired efficacy ( Piecemeal deglutition and oropharyngeal residue).
timeFrame: up to 3 months follow-up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de l'Esperança
Study officials:
affiliation: Parc de Salut Mar
name: Anna Guillen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wheeler KM, Chiara T, Sapienza CM. Surface electromyographic activity of the submental muscles during swallow and expiratory pressure threshold training tasks. Dysphagia. 2007 Apr;22(2):108-16. doi: 10.1007/s00455-006-9061-4. Epub 2007 Feb 10.
citation: Huckabee ML, Doeltgen S. Emerging modalities in dysphagia rehabilitation: neuromuscular electrical stimulation. N Z Med J. 2007 Oct 12;120(1263):U2744.
citation: Logemann JA. The effects of VitalStim on clinical and research thinking in dysphagia. Dysphagia. 2007 Jan;22(1):11-2. doi: 10.1007/s00455-006-9039-2. Epub 2007 Jan 10. No abstract available.
citation: Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
citation: Chiara T, Martin AD, Davenport PW, Bolser DC. Expiratory muscle strength training in persons with multiple sclerosis having mild to moderate disability: effect on maximal expiratory pressure, pulmonary function, and maximal voluntary cough. Arch Phys Med Rehabil. 2006 Apr;87(4):468-73. doi: 10.1016/j.apmr.2005.12.035.
citation: Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.