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DysphagiaPhase 4NCT02473432

Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

A Phase 4 study testing NMES in people with Dysphagia, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysphagia
What is being tested?
NMES
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteSpain
Study dates
Dec 2013to Sep 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de l'Esperança

    Barcelona, Barcelona, 08024

Other trials in Spain

About this study

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

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.

Read the 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
Dysphagia
Being tested
RMT + usual care, NMES, Usual care
Keywords
respiratory muscle training, neuromuscular electrical stimulation, oropharyngeal dysphagia, stroke, rehabilitation
Medical subject headings
Deglutition Disorders, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RMT + usual careProcedure or surgery

    Also called Respiratory muscle training + usual care

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

  • NMESProcedure or surgery

    Also called Neuromuscular electrical stimulation + usual care

    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.

  • Usual careProcedure or surgery

    Also called Standard swallow therapy

    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.

Study groups in NCT02473432
Study groupRoleWhat they receive
RMT + usual careExperimentalDevice: 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.
Receives: Procedure: RMT + usual care
NMES + usual careExperimentalDevice: 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).
Receives: Procedure: NMES
Usual careActive comparatorUsual 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.
Receives: Procedure: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: up to 3 months follow-up

Secondary outcomes (3)

  1. 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.

    Measured: up to 3 months follow-up

  2. 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).

    Measured: up to 3 months follow-up

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

    Measured: up to 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionJun 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473432
Sponsor's protocol ID
PSM/RHB/NR/15
Status last verified
Feb 2016
First submitted
12 Jun 2015
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17294298

  • Huckabee ML, Doeltgen S. Emerging modalities in dysphagia rehabilitation: neuromuscular electrical stimulation. N Z Med J. 2007 Oct 12;120(1263):U2744.

    PubMed 17972964

  • 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.

    PubMed 17216392

  • 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.

    PubMed 16269630

  • 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.

    PubMed 16571384

  • 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.

    PubMed 25503549

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NMES in people with Dysphagia, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Penetration Aspiration Scale (time frame: up to 3 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473432, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.

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