Abdominal Functional Electrical Stimulation Training and Its Effect on Mechanical Insufflation-Exsufflation

NCT01800409 | Unknown

• 1 other identifier: GN12NE539
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Compromised respiratory function as a result of tetraplegia is a leading cause of rehospitalisation for the tetraplegic patient group. Electrical stimulation of the abdominal muscles has previously been used to improve the respiratory function of tetraplegic patients in the chronic stage of injury. In this study the investigators aim to evaluate the optimum protocol for the use of electrical stimulation of the abdominal muscles to improve the respiratory function of the tetraplegic population. The investigators also aim to investigate whether abdominal functional electrical stimulation combined with mechanical insufflation-exsufflation can be used to help further improve the respiratory function of the tetraplegic population.

Conditions

Cervical Spinal Cord Injury

Keywords

Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Respiratory function

  Forced Vital Capacity (FVC) tests will be performed with and without abdominal stimulation, which provides a measure of the participant's Vital Capacity (VC), Forced Exhaled Volume in one second (FEV1) and Peak Expiratory Flow (PEF). Respiratory flow and volume will be measured using a spirometer.

  at end of 8 week AFES intervention

Secondary Outcomes (3)

• the total excursion of the diaphragm under both stimulated and unstimulated conditions

  at end of 8 week AFES intervention

• the cough peak flow generated through unassisted MI-E, manually-assisted MI-E and AFES-assisted MI-E

  at end of 8 week AFES intervention

• Patient's experience of using MI-E combined with AFES compared to the use of clinically established techniques

  at end of 8 week AFES intervention

Study Arms (2)

AFES training

EXPERIMENTAL

Participants will take part in AFES training sessions five times per week (Mon-Fri) for a total of 8 weeks During these sessions participants will receive AFES for 40 minutes. Training sessions are designed to strengthen the participants abdominal muscles in order to improve respiratory function

Device: AFES

Control period

NO INTERVENTION

Four week control period. The order of the control and training periods will be randomised for each participant.

Interventions

AFES DEVICE

During the stimulation sessions electrical stimulation will be applied for 40 minutes per day, 5 days per week for a total of 8 weeks

Also known as: neuromuscular stimulator (RehaStim, HasoMed, Germany)

AFES training

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over 16 years of age
• Reduced respiratory function as a result of a cervical spinal cord injury
• Good visual response to surface abdominal stimulation, suggesting that lower motor neurons are intact
• Ventilator independent

You may not qualify if:

• Under 16 years of age
• Female subjects who are pregnant
• Significant history of autonomic dysreflexia
• No visual response to surface abdominal stimulation, suggesting that lower motor neurons are not intact
• Unstable chest or abdominal injury
• High levels of intrinsic PEEP (bulleous disease, lung tumour etc)
• High anastomosis (e.g. oesophago-gastrectomy)
• Bulbar dysfunction
• Unable to give informed consent

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Related Publications (12)

• Cardozo CP. Respiratory complications of spinal cord injury. J Spinal Cord Med. 2007;30(4):307-8. doi: 10.1080/10790268.2007.11753945. No abstract available.

  PMID: 17853651 BACKGROUND

• Sancho J, Servera E, Vergara P, Marin J. Mechanical insufflation-exsufflation vs. tracheal suctioning via tracheostomy tubes for patients with amyotrophic lateral sclerosis: a pilot study. Am J Phys Med Rehabil. 2003 Oct;82(10):750-3. doi: 10.1097/01.PHM.0000087456.28979.2E.

  PMID: 14508404 BACKGROUND

• Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.

  PMID: 11359958 BACKGROUND

• Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993 Nov;104(5):1553-62. doi: 10.1378/chest.104.5.1553.

  PMID: 8222823 BACKGROUND

• Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000 Nov;118(5):1390-6. doi: 10.1378/chest.118.5.1390.

  PMID: 11083691 BACKGROUND

• Linn WS, Spungen AM, Gong H Jr, Adkins RH, Bauman WA, Waters RL. Forced vital capacity in two large outpatient populations with chronic spinal cord injury. Spinal Cord. 2001 May;39(5):263-8. doi: 10.1038/sj.sc.3101155.

  PMID: 11438842 BACKGROUND

• Bott J, Blumenthal S, Buxton M, Ellum S, Falconer C, Garrod R, Harvey A, Hughes T, Lincoln M, Mikelsons C, Potter C, Pryor J, Rimington L, Sinfield F, Thompson C, Vaughn P, White J; British Thoracic Society Physiotherapy Guideline Development Group. Guidelines for the physiotherapy management of the adult, medical, spontaneously breathing patient. Thorax. 2009 May;64 Suppl 1:i1-51. doi: 10.1136/thx.2008.110726. No abstract available.

  PMID: 19406863 BACKGROUND

• Cheng PT, Chen CL, Wang CM, Chung CY. Effect of neuromuscular electrical stimulation on cough capacity and pulmonary function in patients with acute cervical cord injury. J Rehabil Med. 2006 Jan;38(1):32-6. doi: 10.1080/16501970510043387.

  PMID: 16548084 BACKGROUND

• Sorli J, Kandare F, Jaeger RJ, Stanic U. Ventilatory assistance using electrical stimulation of abdominal muscles. IEEE Trans Rehabil Eng. 1996 Mar;4(1):1-6. doi: 10.1109/86.486051.

  PMID: 8798066 BACKGROUND

• Jaeger RJ, Turba RM, Yarkony GM, Roth EJ. Cough in spinal cord injured patients: comparison of three methods to produce cough. Arch Phys Med Rehabil. 1993 Dec;74(12):1358-61. doi: 10.1016/0003-9993(93)90093-p.

  PMID: 8018145 BACKGROUND

• Langbein WE, Maloney C, Kandare F, Stanic U, Nemchausky B, Jaeger RJ. Pulmonary function testing in spinal cord injury: effects of abdominal muscle stimulation. J Rehabil Res Dev. 2001 Sep-Oct;38(5):591-7.

  PMID: 11732836 BACKGROUND

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Gollee, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Gollee, PhD

CONTACT

44-141-330-4406; Henrik.gollee@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

GB (1)