NCT02473432

Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

Neuromuscular Electroestimulation and Respiratory Muscle Training in the Management of Dysphagia of Subacute Stroke Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
PROCEDURE	RMT + usual care	Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)
PROCEDURE	NMES	Neuromuscular electrical stimulation is performed with the Vital Stim ® device (approved by the FDA for dysphagia treatment). It consists in the placement of two electrodes located in suprahyoid muscles as above described.
PROCEDURE	Usual care	Standard swallow therapy consists of physiotherapy, occupational therapy and speech therapy targeting specific swallow impairments. In the case of dysphagia, the standard pattern includes measures to protect the airway and compensatory techniques.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2015-06-16
• Last updated: 2016-02-17

Locations

1 site across 1 country: Spain