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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
Sponsor:
Information provided by (Responsible Party):
Esther Marco Navarro, 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.

Condition or disease Intervention/treatment Phase
Dysphagia Procedure: RMT + usual care Procedure: NMES Procedure: Usual care Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
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Spain
Hospital de l'Esperança
Barcelona, Spain, 08024
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Anna Guillen, MD Parc de Salut Mar

Publications:
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Responsible Party: Esther Marco Navarro, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02473432     History of Changes
Other Study ID Numbers: PSM/RHB/NR/15
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Esther Marco Navarro, Parc de Salut Mar:
respiratory muscle training
neuromuscular electrical stimulation
oropharyngeal dysphagia
stroke
rehabilitation
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases