Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke

NCT02473432 | Completed Phase 4

• 1 other identifier: PSM/RHB/NR/15
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

respiratory muscle training; neuromuscular electrical stimulation; oropharyngeal dysphagia; stroke; rehabilitation

Outcome Measures

Primary Outcomes (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)

  up to 3 months follow-up

Secondary Outcomes (3)

• Maximal inspiratory and expiratory muscle strength

  up to 3 months follow-up

• Security of swallowing oral phase

  up to 3 months follow-up

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

  up to 3 months follow-up

Study Arms (3)

RMT + usual care

EXPERIMENTAL

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

NMES + usual care

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

RMT + usual care PROCEDURE

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

Also known as: Respiratory muscle training + usual care

RMT + usual care

NMES PROCEDURE

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.

Also known as: Neuromuscular electrical stimulation + usual care

NMES + usual care

Usual care PROCEDURE

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.

Also known as: Standard swallow therapy

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital de l'Esperança

Barcelona, Barcelona, 08024, Spain

Location

Related Publications (6)

• 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.

  PMID: 17294298 BACKGROUND

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

  PMID: 17972964 BACKGROUND

• 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.

  PMID: 17216392 BACKGROUND

• 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.

  PMID: 16269630 BACKGROUND

• 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.

  PMID: 16571384 BACKGROUND

• 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.

  PMID: 25503549 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Anna Guillen, MD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

ES (1)