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Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

Primary Purpose

Dysphagia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
RMT + usual care
NMES
Usual care
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring respiratory muscle training, neuromuscular electrical stimulation, oropharyngeal dysphagia, stroke, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de l'Esperança

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

RMT + usual care

NMES + usual care

Usual care

Arm 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.

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).

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.

Outcomes

Primary Outcome Measures

Penetration Aspiration Scale
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

Maximal inspiratory and expiratory muscle strength
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
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).

Full Information

First Posted
June 12, 2015
Last Updated
February 15, 2016
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT02473432
Brief Title
Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke
Official Title
Neuromuscular Electroestimulation and Respiratory Muscle Training in the Management of Dysphagia of Subacute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
respiratory muscle training, neuromuscular electrical stimulation, oropharyngeal dysphagia, stroke, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RMT + usual care
Arm Type
Experimental
Arm 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.
Arm Title
NMES + usual care
Arm Type
Experimental
Arm 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).
Arm Title
Usual care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
RMT + usual care
Other Intervention Name(s)
Respiratory muscle training + usual care
Intervention Description
Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)
Intervention Type
Procedure
Intervention Name(s)
NMES
Other Intervention Name(s)
Neuromuscular electrical stimulation + usual care
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Other Intervention Name(s)
Standard swallow therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Penetration Aspiration Scale
Description
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)
Time Frame
up to 3 months follow-up
Secondary Outcome Measure Information:
Title
Maximal inspiratory and expiratory muscle strength
Description
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.
Time Frame
up to 3 months follow-up
Title
Security of swallowing oral phase
Description
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).
Time Frame
up to 3 months follow-up
Title
Number of participants with signs of impaired efficacy ( Piecemeal deglutition and oropharyngeal residue).
Time Frame
up to 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Guillen, MD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de l'Esperança
City
Barcelona
ZIP/Postal Code
08024
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17294298
Citation
Wheeler KM, Chiara T, Sapienza CM. Surface electromyographic activity of the submental muscles during swallow and expiratory pressure threshold training tasks. Dysphagia. 2007 Apr;22(2):108-16. doi: 10.1007/s00455-006-9061-4. Epub 2007 Feb 10.
Results Reference
background
PubMed Identifier
17972964
Citation
Huckabee ML, Doeltgen S. Emerging modalities in dysphagia rehabilitation: neuromuscular electrical stimulation. N Z Med J. 2007 Oct 12;120(1263):U2744.
Results Reference
background
PubMed Identifier
17216392
Citation
Logemann JA. The effects of VitalStim on clinical and research thinking in dysphagia. Dysphagia. 2007 Jan;22(1):11-2. doi: 10.1007/s00455-006-9039-2. Epub 2007 Jan 10. No abstract available.
Results Reference
background
PubMed Identifier
16269630
Citation
Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
Results Reference
background
PubMed Identifier
16571384
Citation
Chiara T, Martin AD, Davenport PW, Bolser DC. Expiratory muscle strength training in persons with multiple sclerosis having mild to moderate disability: effect on maximal expiratory pressure, pulmonary function, and maximal voluntary cough. Arch Phys Med Rehabil. 2006 Apr;87(4):468-73. doi: 10.1016/j.apmr.2005.12.035.
Results Reference
background
PubMed Identifier
25503549
Citation
Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.
Results Reference
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Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

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