Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke
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|ClinicalTrials.gov Identifier: NCT02473432|
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Procedure: RMT + usual care Procedure: NMES Procedure: Usual care||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Neuromuscular Electroestimulation and Respiratory Muscle Training in the Management of Dysphagia of Subacute Stroke Patients|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||September 2015|
Experimental: RMT + usual care
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.
Procedure: RMT + usual care
Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)
Other Name: Respiratory muscle training + usual care
Experimental: NMES + usual care
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).
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 Name: Neuromuscular electrical stimulation + usual care
Active Comparator: Usual care
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.
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.
Other Name: Standard swallow therapy
- 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)
- 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.
- 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).
- Number of participants with signs of impaired efficacy ( Piecemeal deglutition and oropharyngeal residue). [ Time Frame: up to 3 months follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473432
|Hospital de l'Esperança|
|Barcelona, Spain, 08024|
|Principal Investigator:||Anna Guillen, MD||Parc de Salut Mar|