Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

Completed

Phase 4 Results N/A

Trial Description

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

Interventions

  • Usual care Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual care
    Description: Usual care (standard multidisciplinary inpatient rehabilitation program) consisting of physical, occupational and speech therapy sessions to improve activities of daily life, mobility and communication skills (minimum 3 hours per day, 5 days a week, during 3 weeks), Standard swallow therapy (usual care of dysphagia in stroke patients) 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.
  • Vital Stim ® Device
    Intervention Desc: The Vital Stim ® device is the only neuromuscular electrical stimulation device approved by the FDA for dysphagia treatment. It consists in the placement of two electrode located in suprahyoid muscles as above described.
    ARM 1: Kind: Experimental
    Label: NMES + sham RMT + usual care
    Description: Neuromuscular electrical stimulation consists: adminitration of 80 Hz transcutaneous electrical stimulus (biphasic using the Intelect Vital Stim device (Chattanooga Group, Hixson, TN, USA), Schedule: 40 minutes per day, 5 sessions per week (Monday to Friday) during hospitalization in the Neurorehabilitation ward (3 weeks approx).
  • Respiratory muscle training Other
    Intervention Desc: Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)
    ARM 1: Kind: Experimental
    Label: RMT + usual care
    Description: Respiratory muscle training with the Orygen-Dual® valve trainer (a respiratory device that allows patients to train inspiratory and expiratory muscles simultaneously). Training loads are set to a pressure equivalent to 30% of maximal respiratory pressures. These external pressures are increased weekly at intervals of 10 cmH2O as tolerated. Training schedule: 5 sets of 10 repetitions followed by 1-2 minutes of unloaded recovery breathing off the device, Two sessions per day, 5 days per week, for 3 weeks, with the assistance of a therapist to ensure that the valve titration display is not visible to patients.
    ARM 2: Kind: Experimental
    Label: NMES + sham RMT + usual care
    Description: Neuromuscular electrical stimulation consists: adminitration of 80 Hz transcutaneous electrical stimulus (biphasic using the Intelect Vital Stim device (Chattanooga Group, Hixson, TN, USA), Schedule: 40 minutes per day, 5 sessions per week (Monday to Friday) during hospitalization in the Neurorehabilitation ward (3 weeks approx).
    ARM 3: Kind: Experimental
    Label: Usual care
    Description: Usual care (standard multidisciplinary inpatient rehabilitation program) consisting of physical, occupational and speech therapy sessions to improve activities of daily life, mobility and communication skills (minimum 3 hours per day, 5 days a week, during 3 weeks), Standard swallow therapy (usual care of dysphagia in stroke patients) 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.
  • Orygen Dual valve Device
    ARM 1: Kind: Experimental
    Label: RMT + usual care
    Description: Respiratory muscle training with the Orygen-Dual® valve trainer (a respiratory device that allows patients to train inspiratory and expiratory muscles simultaneously). Training loads are set to a pressure equivalent to 30% of maximal respiratory pressures. These external pressures are increased weekly at intervals of 10 cmH2O as tolerated. Training schedule: 5 sets of 10 repetitions followed by 1-2 minutes of unloaded recovery breathing off the device, Two sessions per day, 5 days per week, for 3 weeks, with the assistance of a therapist to ensure that the valve titration display is not visible to patients.
  • RMT + usual care Procedure
    Other Names: Respiratory muscle training + usual care
    Intervention Desc: Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)
    ARM 1: Kind: Experimental
    Label: RMT + usual care
    Description: Device: Orygen-Dual® valve trainer Intensity: 30% of maximal respiratory pressures (increasing intervals: 10 cmH2O per week) Training schedule: 5 sets of 10 repetitions followed by 1-2 minutes of unloaded recovery breathing off the device, two sessions per day, 5 days per week, for 3 weeks.
  • NMES Other
    Other Names: Neuromuscular electric stimulation
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: NMES + usual care
    Description: Device: Vital Stim (Chattanooga Group, Hixson, TN, USA) Administration of 80 Hz transcutaneous electrical biphasic stimulus Schedule: 40 minutes per day, 5 sessions per week during hospitalization in the Neurorehabilitation ward (3 weeks approx).

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Penetration Aspiration Scale up to 3 months follow-up No
Secondary Maximal inspiratory and expiratory muscle strength up to 3 months follow-up No
Secondary Security of swallowing oral phase up to 3 months follow-up Yes
Secondary Number of participants with signs of impaired efficacy ( Piecemeal deglutition and oropharyngeal residue). up to 3 months follow-up No

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