Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

Phase 4

Completed

• Conditions: Dysphagia

• Registration Number: NCT02473432
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-16
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale	up to 3 months follow-up	Videofluoroscopy swallow assessment with the 8-point Penetration Aspiration Scale (PAS): PAS score of 1 indicates a normal test, scores from 2 to 5 indicate passage of material into the larynx that does not pass below the vocal folds (penetration) and scores from 6 to 8 indicate passage of material below the level of vocal folds (aspiration)

Secondary Outcome Measures

Name	Time	Method
Security of swallowing oral phase	up to 3 months follow-up	Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) are assessed with the Volume Viscosity Swallow Test:(V-VST).
Maximal inspiratory and expiratory muscle strength	up to 3 months follow-up	Maximal respiratory muscle strength is assessed through maximal inspiratory and expiratory pressures (PImax and PEmax, respectively) measured at the mouth. To determine respiratory pressures, patients were urged to perform a maximum inspiration from residual volume against an occluded airway and a maximum expiratory effort from total lung capacity.
Number of participants with signs of impaired efficacy ( Piecemeal deglutition and oropharyngeal residue).	up to 3 months follow-up

Trial Locations

Locations (1)

Hospital de l'Esperança; 🇪🇸 Barcelona, Spain