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NCT Number: NCT02473432

Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

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.

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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de l'Esperança

Barcelona, 08024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

RMT + usual care

Procedure

Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)

Other names: Respiratory muscle training + usual care

NMES

Procedure

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.

Other names: Neuromuscular electrical stimulation + usual care

usual care

Procedure

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.

Other names: Standard swallow therapy

Primary outcomes

  1. Penetration Aspiration Scale

    Time frame: 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 outcomes

  1. Maximal inspiratory and expiratory muscle strength

    Time frame: 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.

  2. Security of swallowing oral phase

    Time frame: 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).

  3. Number of participants with signs of impaired efficacy ( Piecemeal deglutition and oropharyngeal residue).

    Time frame: up to 3 months follow-up

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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