RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome
NCT ID: NCT05461898
Last Updated: 2025-04-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-01-01
Study Completion Date
2026-12-31
Brief Summary
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Guillain-Barré syndrome (GBS) is a neurological disease characterized by an inflammation of peripheral nerves, which might be responsible for long-term disability.
Respiratory muscle weakness is a complication of GBS and might be responsible for respiratory symptoms, inadequate secretion clearance or hypoventilation, with negative impact on daily life.
Inspiratory muscle training has been applied in respiratory and neurological diseases and benefits have been observed in symptoms (e.g., dyspnoea), pulmonary function, exercise capacity and quality of life. Nevertheless, results of this intervention in people with GBS are yet unknown. Moreover, rehabilitation is a key player in the recovery of these highly complex patients, however, the interpretation of the magnitude of its effects has been limited by the absence of minimal clinically important differences for most outcome measures. To overcome these drawbacks, methodologically robust trials are needed to build evidence-based rehabilitation to improve clinical care on GBS.
The primary aim of this project (RehabGBs) is to develop an inspiratory muscle training protocol - InspireGBs and assess its effects on respiratory muscle strength, peak cough flow, pulmonary function, dyspnoea, fatigue, functional status and quality of life in people with GBS, through a randomised controlled trial. Secondary aims are to: i) establish minimal clinically important differences of Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Medical Research Council - Manual Muscle Testing, Vital capacity, Maximal Inspiratory Pressure, Peak Cough Flow, Functional Independence Measure and Quality of Life for inpatient rehabilitation programmes of people with GBS ii) Evaluate the prevalence of nocturnal hypoventilation in GBS.
Respiratory muscle weakness is a complication of GBS and might be responsible for respiratory symptoms, inadequate secretion clearance or hypoventilation, with negative impact on daily life.
Inspiratory muscle training has been applied in respiratory and neurological diseases and benefits have been observed in symptoms (e.g., dyspnoea), pulmonary function, exercise capacity and quality of life. Nevertheless, results of this intervention in people with GBS are yet unknown. Moreover, rehabilitation is a key player in the recovery of these highly complex patients, however, the interpretation of the magnitude of its effects has been limited by the absence of minimal clinically important differences for most outcome measures. To overcome these drawbacks, methodologically robust trials are needed to build evidence-based rehabilitation to improve clinical care on GBS.
The primary aim of this project (RehabGBs) is to develop an inspiratory muscle training protocol - InspireGBs and assess its effects on respiratory muscle strength, peak cough flow, pulmonary function, dyspnoea, fatigue, functional status and quality of life in people with GBS, through a randomised controlled trial. Secondary aims are to: i) establish minimal clinically important differences of Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Medical Research Council - Manual Muscle Testing, Vital capacity, Maximal Inspiratory Pressure, Peak Cough Flow, Functional Independence Measure and Quality of Life for inpatient rehabilitation programmes of people with GBS ii) Evaluate the prevalence of nocturnal hypoventilation in GBS.
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Detailed Description
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Guillain-Barré syndrome (GBS) is an acute inflammatory demyelinating polyradiculoneuropathy and is the most common cause of acute flaccid paralysis. Its annual global incidence is between 0.8 - 1.9 cases per 100,000 people.
GBS is usually preceded by infection or other immune stimulation that induces an aberrant autoimmune response targeting peripheral nerves and their spinal roots. It is characterized by rapid progressive bilateral muscle weakness of the lower limbs and/or arms, in combination with hyporeflexia or areflexia, and most patients reach their maximum disability within 2-4 weeks.Various phenotypes have been described, including acute inflammatory demyelinating polyradiculoneuropathy, acute motor axonal neuropathy, acute motor sensory axonal neuropathy and Miller-Fisher syndrome.
Overall, the clinical course, severity and outcomes of people with GBS are highly heterogeneous. Significant disability, including incomplete recovery of motor (i.e., ambulation) and sensory function, as well as fatigue, pain, respiratory insufficiency and psychological distress might exist after the acute phase. But long-term significant impacts, two years after the onset, on daily activities, work, social activities and health-related quality of life have also been reported. The most often feature is an impairment of the motor capacity, but respiratory muscle weakness is a common complication in people with GBS and may result in decrease vital capacity, chest wall expansion and coughing strength, causing atelectasis and pulmonary infections. Therefore, it is generally accepted that respiratory muscle weakness causes increased morbidity and mortality, owing to the combination of poor airway protection, inadequate secretion clearance and hypoventilation. Previous studies already identified these clinical manifestations in acute GBS. However, prevalence of hypoventilation and inspiratory muscle weakness in subacute phase of GBS is still unknown. Early recognition and treatment of respiratory muscle weakness is important in people with GBS and physiotherapy interventions may be useful to successfully manage these patients.
Inspiratory muscle training (IMT) is a cheap and free of side-effects therapeutic modality, which consists of breathing exercises using a pressure threshold device, that has been applied in several diseases. In patients with chronic obstructive pulmonary disease, IMT improve inspiratory muscle function, exertional dyspnoea and exercise capacity. In patients with neuromuscular disease, has been suggested that IMT increases inspiratory muscle strength and lung volumes, especially in those with muscular dystrophies. In addition, a randomized control trial concluded that IMT in acute patients increases inspiratory muscle strength and quality of life. However, there are no studies about rehabilitation approaches, such IMT, to improve symptoms (i.e. dyspnoea or fatigue), pulmonary function, functional status and quality of life in people with GBS.
Rehabilitation, namely inpatient rehabilitation programmes, is therefore key for the recovery of symptoms, functional outcomes, community participation and quality of life of these highly complex patients. Nevertheless, insufficient high-quality literature, still precludes definitive conclusions about the effects of rehabilitation in people with GBS. Additionally, the interpretation of the magnitude of its effects is challenging due to the lack of minimal clinically important differences (MCIDs) for most outcome measures used in rehabilitation of people with GBS. A MCIDs is the smallest change in a measure that will be perceived as an important improvement for the patient. Such values constitute thresholds for clinical meaningfulness. Therefore, establishing MCIDs is essential to determine effectiveness of rehabilitation and guide clinical decision-making in the management of people with GBS.
In conclusion, by developing and implementing RehabGBs, we will contribute to build evidence-based rehabilitation practices and optimise care in GBS, by: i) assessing the effects of IMT in people with GBS; ii) establishing minimal clinical important differences of rehabilitation outcome measures, to help clinicians better understand the magnitude of the effects of the intervention and determine effectiveness of rehabilitation in people with GBS; iii) evaluate the prevalence of nocturnal hypoventilation in people with GBS.
Therefore, the primary aim of RehabGBs is to:
1\. Evaluate, through a randomised controlled trial, the effects of InspireGBs - inspiratory muscle training protocol on respiratory muscle strength, peak cough flow, lung function, dyspnoea, fatigue, functional status and quality of life in people with GBS.
The secondary aims of the project are to:
1. Establish the MCIDs for rehabilitation programmes in people with GBS for Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Modified Borg Scale, Medical Research Council - Manual Muscle Testing, Vital capacity, Maximal Inspiratory pressure, Peak Cough Flow, Functional Independence Measure and EuroQol Five-Dimensional Questionnaire.
2. Evaluate the prevalence of nocturnal hypoventilation in people with sub-acute GBS.
Study Design \& Intervention
InspireGBs is an inspiratory muscle training programme which will be implemented to people with GBS for 6 weeks during an inpatient rehabilitation programme. They will receive IMT for 5 days/week using the PowerBreath KH2. This handheld device applies a constant resistance provided by a electronic-controlled valve. Training will be set initially at a load of approximately 50% of patients' maximal inspiratory mouth pressure. This initial load will be daily increased during the programme based on symptom scores (modified Borg dyspnoea Scale ratings of 4-6 of 10).Total daily training time will consist of 6 cycles of 30 breaths (3 cycles, twice daily).
Patients will be recruited as described and randomly allocated by a computer-generated adaptive random allocation schedule (in a ratio 1:1) to either the experimental or control groups. All participants will receive the inpatient rehabilitation programme. This programme will be tailored to each patient, with approximately 5 hours of intervention/day for 5 days/week (typically for 14 weeks). An interdisciplinary team composed of physiotherapy; occupational therapy; speech and language therapy; and medical, pharmacological, nursery, psychology, clinical dietitian and social worker will be involved, as needed.
Sample Size Estimation
Based on an inspiratory muscle training study conducted in people with spinal cord injury, it is anticipated that a minimum of 64 participants (32 in each group) will be needed to detect a between-group difference of 10 cmH2O in the primary outcome measure (power=80%, α=0.05, 2-tailed). Since in GBS rehabilitation interventions dropout rates are around 15%, 74 participants will be needed.
GBS is usually preceded by infection or other immune stimulation that induces an aberrant autoimmune response targeting peripheral nerves and their spinal roots. It is characterized by rapid progressive bilateral muscle weakness of the lower limbs and/or arms, in combination with hyporeflexia or areflexia, and most patients reach their maximum disability within 2-4 weeks.Various phenotypes have been described, including acute inflammatory demyelinating polyradiculoneuropathy, acute motor axonal neuropathy, acute motor sensory axonal neuropathy and Miller-Fisher syndrome.
Overall, the clinical course, severity and outcomes of people with GBS are highly heterogeneous. Significant disability, including incomplete recovery of motor (i.e., ambulation) and sensory function, as well as fatigue, pain, respiratory insufficiency and psychological distress might exist after the acute phase. But long-term significant impacts, two years after the onset, on daily activities, work, social activities and health-related quality of life have also been reported. The most often feature is an impairment of the motor capacity, but respiratory muscle weakness is a common complication in people with GBS and may result in decrease vital capacity, chest wall expansion and coughing strength, causing atelectasis and pulmonary infections. Therefore, it is generally accepted that respiratory muscle weakness causes increased morbidity and mortality, owing to the combination of poor airway protection, inadequate secretion clearance and hypoventilation. Previous studies already identified these clinical manifestations in acute GBS. However, prevalence of hypoventilation and inspiratory muscle weakness in subacute phase of GBS is still unknown. Early recognition and treatment of respiratory muscle weakness is important in people with GBS and physiotherapy interventions may be useful to successfully manage these patients.
Inspiratory muscle training (IMT) is a cheap and free of side-effects therapeutic modality, which consists of breathing exercises using a pressure threshold device, that has been applied in several diseases. In patients with chronic obstructive pulmonary disease, IMT improve inspiratory muscle function, exertional dyspnoea and exercise capacity. In patients with neuromuscular disease, has been suggested that IMT increases inspiratory muscle strength and lung volumes, especially in those with muscular dystrophies. In addition, a randomized control trial concluded that IMT in acute patients increases inspiratory muscle strength and quality of life. However, there are no studies about rehabilitation approaches, such IMT, to improve symptoms (i.e. dyspnoea or fatigue), pulmonary function, functional status and quality of life in people with GBS.
Rehabilitation, namely inpatient rehabilitation programmes, is therefore key for the recovery of symptoms, functional outcomes, community participation and quality of life of these highly complex patients. Nevertheless, insufficient high-quality literature, still precludes definitive conclusions about the effects of rehabilitation in people with GBS. Additionally, the interpretation of the magnitude of its effects is challenging due to the lack of minimal clinically important differences (MCIDs) for most outcome measures used in rehabilitation of people with GBS. A MCIDs is the smallest change in a measure that will be perceived as an important improvement for the patient. Such values constitute thresholds for clinical meaningfulness. Therefore, establishing MCIDs is essential to determine effectiveness of rehabilitation and guide clinical decision-making in the management of people with GBS.
In conclusion, by developing and implementing RehabGBs, we will contribute to build evidence-based rehabilitation practices and optimise care in GBS, by: i) assessing the effects of IMT in people with GBS; ii) establishing minimal clinical important differences of rehabilitation outcome measures, to help clinicians better understand the magnitude of the effects of the intervention and determine effectiveness of rehabilitation in people with GBS; iii) evaluate the prevalence of nocturnal hypoventilation in people with GBS.
Therefore, the primary aim of RehabGBs is to:
1\. Evaluate, through a randomised controlled trial, the effects of InspireGBs - inspiratory muscle training protocol on respiratory muscle strength, peak cough flow, lung function, dyspnoea, fatigue, functional status and quality of life in people with GBS.
The secondary aims of the project are to:
1. Establish the MCIDs for rehabilitation programmes in people with GBS for Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Modified Borg Scale, Medical Research Council - Manual Muscle Testing, Vital capacity, Maximal Inspiratory pressure, Peak Cough Flow, Functional Independence Measure and EuroQol Five-Dimensional Questionnaire.
2. Evaluate the prevalence of nocturnal hypoventilation in people with sub-acute GBS.
Study Design \& Intervention
InspireGBs is an inspiratory muscle training programme which will be implemented to people with GBS for 6 weeks during an inpatient rehabilitation programme. They will receive IMT for 5 days/week using the PowerBreath KH2. This handheld device applies a constant resistance provided by a electronic-controlled valve. Training will be set initially at a load of approximately 50% of patients' maximal inspiratory mouth pressure. This initial load will be daily increased during the programme based on symptom scores (modified Borg dyspnoea Scale ratings of 4-6 of 10).Total daily training time will consist of 6 cycles of 30 breaths (3 cycles, twice daily).
Patients will be recruited as described and randomly allocated by a computer-generated adaptive random allocation schedule (in a ratio 1:1) to either the experimental or control groups. All participants will receive the inpatient rehabilitation programme. This programme will be tailored to each patient, with approximately 5 hours of intervention/day for 5 days/week (typically for 14 weeks). An interdisciplinary team composed of physiotherapy; occupational therapy; speech and language therapy; and medical, pharmacological, nursery, psychology, clinical dietitian and social worker will be involved, as needed.
Sample Size Estimation
Based on an inspiratory muscle training study conducted in people with spinal cord injury, it is anticipated that a minimum of 64 participants (32 in each group) will be needed to detect a between-group difference of 10 cmH2O in the primary outcome measure (power=80%, α=0.05, 2-tailed). Since in GBS rehabilitation interventions dropout rates are around 15%, 74 participants will be needed.
Conditions
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Guillain-Barré Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Single blind
Study Groups
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Inpatient Rehabilitation + Inspiratory Muscle Training
* The inpatient rehabilitation program included individualized, functional goal-oriented treatment, with approximately 5 hours of intervention a day, 5 days/week for a total of 6 weeks, with integrated rehabilitation care.
* The inspiratory muscle training included a 6 weeks intervention with electronic-controlled valve device
Group Type
EXPERIMENTAL
Inpatient Rehabilitation
Intervention Type
OTHER
Standard inpatient rehabilitation program with a interdisciplinary team that included a physiotherapist who ensured muscle strength, balance, aerobic and functional training, an occupational therapist who provided training of basic and instrumental activities of daily living and education of energy conservation techniques and a a speech and language therapist for swallowing training.
Inspiratory muscle training
Intervention Type
OTHER
Inspiratory muscle training protocol during 6 weeks with a electronic-controlled valve device
Inpatient Rehabilitation
\- The inpatient rehabilitation program included individualized, functional goal-oriented treatment, with approximately 5 hours of intervention a day, 5 days/week for a total of 6 weeks, with integrated rehabilitation care.
Group Type
ACTIVE_COMPARATOR
Inpatient Rehabilitation
Intervention Type
OTHER
Standard inpatient rehabilitation program with a interdisciplinary team that included a physiotherapist who ensured muscle strength, balance, aerobic and functional training, an occupational therapist who provided training of basic and instrumental activities of daily living and education of energy conservation techniques and a a speech and language therapist for swallowing training.
Interventions
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Inpatient Rehabilitation
Standard inpatient rehabilitation program with a interdisciplinary team that included a physiotherapist who ensured muscle strength, balance, aerobic and functional training, an occupational therapist who provided training of basic and instrumental activities of daily living and education of energy conservation techniques and a a speech and language therapist for swallowing training.
Intervention Type
OTHER
Inspiratory muscle training
Inspiratory muscle training protocol during 6 weeks with a electronic-controlled valve device
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* ≥18 years
* diagnosed with Guillain Barré Syndrome
* willing to participate in an inpatient rehabilitation program
* able to provide informed consent
* diagnosed with Guillain Barré Syndrome
* willing to participate in an inpatient rehabilitation program
* able to provide informed consent
Exclusion Criteria
* presence of significant cardiac and musculoskeletal diseases
* tracheostomized patients
* signs of cognitive impairment or current neoplastic or immunological disease which may preclude their participation in the rehabilitation program and participation in any other therapeutic intervention in addition to standard of care.
* tracheostomized patients
* signs of cognitive impairment or current neoplastic or immunological disease which may preclude their participation in the rehabilitation program and participation in any other therapeutic intervention in addition to standard of care.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Aveiro University
OTHER
Sponsor Role
collaborator
Centro de Reabilitacao do Norte
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alda S Marques, PhD
Role: STUDY_DIRECTOR
School of Health Sciences, University of Aveiro (ESSUA)
Locations
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Centro de Reabilitação do Norte
Vila Nova de Gaia, , Portugal
Site Status
RECRUITING
Countries
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Portugal
Central Contacts
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Sofia A Viamonte, MSc
Role: CONTACT
00351220901200
Facility Contacts
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References
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Leonhard SE, Mandarakas MR, Gondim FAA, Bateman K, Ferreira MLB, Cornblath DR, van Doorn PA, Dourado ME, Hughes RAC, Islam B, Kusunoki S, Pardo CA, Reisin R, Sejvar JJ, Shahrizaila N, Soares C, Umapathi T, Wang Y, Yiu EM, Willison HJ, Jacobs BC. Diagnosis and management of Guillain-Barre syndrome in ten steps. Nat Rev Neurol. 2019 Nov;15(11):671-683. doi: 10.1038/s41582-019-0250-9. Epub 2019 Sep 20.
Reference Type
BACKGROUND
Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2.
Reference Type
BACKGROUND
van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
Reference Type
BACKGROUND
Forsberg A, Press R, Einarsson U, de Pedro-Cuesta J, Holmqvist LW. Disability and health-related quality of life in Guillain-Barre syndrome during the first two years after onset: a prospective study. Clin Rehabil. 2005 Dec;19(8):900-9. doi: 10.1191/0269215505cr918oa.
Reference Type
BACKGROUND
Green C, Baker T, Subramaniam A. Predictors of respiratory failure in patients with Guillain-Barre syndrome: a systematic review and meta-analysis. Med J Aust. 2018 Mar 5;208(4):181-188. doi: 10.5694/mja17.00552.
Reference Type
BACKGROUND
van den Berg B, Storm EF, Garssen MJP, Blomkwist-Markens PH, Jacobs BC. Clinical outcome of Guillain-Barre syndrome after prolonged mechanical ventilation. J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):949-954. doi: 10.1136/jnnp-2018-317968. Epub 2018 Apr 7.
Reference Type
BACKGROUND
Walterspacher S, Kirchberger A, Lambeck J, Walker DJ, Schworer A, Niesen WD, Windisch W, Hamzei F, Kabitz HJ. Respiratory Muscle Assessment in Acute Guillain-Barre Syndrome. Lung. 2016 Oct;194(5):821-8. doi: 10.1007/s00408-016-9929-5. Epub 2016 Aug 9.
Reference Type
BACKGROUND
Orlikowski D, Prigent H, Sharshar T, Lofaso F, Raphael JC. Respiratory dysfunction in Guillain-Barre Syndrome. Neurocrit Care. 2004;1(4):415-22. doi: 10.1385/NCC:1:4:415.
Reference Type
BACKGROUND
Aslan GK, Gurses HN, Issever H, Kiyan E. Effects of respiratory muscle training on pulmonary functions in patients with slowly progressive neuromuscular disease: a randomized controlled trial. Clin Rehabil. 2014 Jun;28(6):573-81. doi: 10.1177/0269215513512215. Epub 2013 Nov 25.
Reference Type
BACKGROUND
Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, Saey D, Maltais F, Derom E, Vermeersch S, Heijdra YF, van Helvoort H, Garms L, Schneeberger T, Kenn K, Gloeckl R, Langer D. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax. 2018 Oct;73(10):942-950. doi: 10.1136/thoraxjnl-2017-211417. Epub 2018 Jun 18.
Reference Type
BACKGROUND
Boswell-Ruys CL, Lewis CRH, Wijeysuriya NS, McBain RA, Lee BB, McKenzie DK, Gandevia SC, Butler JE. Impact of respiratory muscle training on respiratory muscle strength, respiratory function and quality of life in individuals with tetraplegia: a randomised clinical trial. Thorax. 2020 Mar;75(3):279-288. doi: 10.1136/thoraxjnl-2019-213917. Epub 2020 Jan 14.
Reference Type
BACKGROUND
Koessler W, Wanke T, Winkler G, Nader A, Toifl K, Kurz H, Zwick H. 2 Years' experience with inspiratory muscle training in patients with neuromuscular disorders. Chest. 2001 Sep;120(3):765-9. doi: 10.1378/chest.120.3.765.
Reference Type
BACKGROUND
Bissett BM, Leditschke IA, Neeman T, Boots R, Paratz J. Inspiratory muscle training to enhance recovery from mechanical ventilation: a randomised trial. Thorax. 2016 Sep;71(9):812-9. doi: 10.1136/thoraxjnl-2016-208279. Epub 2016 Jun 2.
Reference Type
BACKGROUND
Simatos Arsenault N, Vincent PO, Yu BH, Bastien R, Sweeney A. Influence of Exercise on Patients with Guillain-Barre Syndrome: A Systematic Review. Physiother Can. 2016;68(4):367-376. doi: 10.3138/ptc.2015-58.
Reference Type
BACKGROUND
Khan F, Amatya B. Rehabilitation interventions in patients with acute demyelinating inflammatory polyneuropathy: a systematic review. Eur J Phys Rehabil Med. 2012 Sep;48(3):507-22. Epub 2012 Jul 23.
Reference Type
BACKGROUND
Sulli S, Scala L, Berardi A, Conte A, Baione V, Belvisi D, Leodori G, Galeoto G. The efficacy of rehabilitation in people with Guillain-Barre syndrome: a systematic review of randomized controlled trials. Expert Rev Neurother. 2021 Apr;21(4):455-461. doi: 10.1080/14737175.2021.1890034. Epub 2021 Feb 23.
Reference Type
BACKGROUND
Malec JF, Ketchum JM. A Standard Method for Determining the Minimal Clinically Important Difference for Rehabilitation Measures. Arch Phys Med Rehabil. 2020 Jun;101(6):1090-1094. doi: 10.1016/j.apmr.2019.12.008. Epub 2020 Jan 15.
Reference Type
BACKGROUND
Khan F, Pallant JF, Amatya B, Ng L, Gorelik A, Brand C. Outcomes of high- and low-intensity rehabilitation programme for persons in chronic phase after Guillain-Barre syndrome: a randomized controlled trial. J Rehabil Med. 2011 Jun;43(7):638-46. doi: 10.2340/16501977-0826.
Reference Type
BACKGROUND
Ogna A, Quera Salva MA, Prigent H, Mroue G, Vaugier I, Annane D, Lofaso F, Orlikowski D. Nocturnal hypoventilation in neuromuscular disease: prevalence according to different definitions issued from the literature. Sleep Breath. 2016 May;20(2):575-81. doi: 10.1007/s11325-015-1247-2. Epub 2015 Sep 4.
Reference Type
BACKGROUND
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
Reference Type
BACKGROUND
Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
Reference Type
BACKGROUND
Bach JR, Goncalves MR, Paez S, Winck JC, Leitao S, Abreu P. Expiratory flow maneuvers in patients with neuromuscular diseases. Am J Phys Med Rehabil. 2006 Feb;85(2):105-11. doi: 10.1097/01.phm.0000197307.32537.40.
Reference Type
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.
Reference Type
BACKGROUND
Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.
Reference Type
BACKGROUND
Merkies IS, Kieseier BC. Fatigue, Pain, Anxiety and Depression in Guillain-Barre Syndrome and Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Eur Neurol. 2016;75(3-4):199-206. doi: 10.1159/000445347. Epub 2016 Apr 15.
Reference Type
BACKGROUND
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Reference Type
BACKGROUND
Andrews AW, Middleton A. Improvement During Inpatient Rehabilitation Among Older Adults With Guillain-Barre Syndrome, Multiple Sclerosis, Parkinson Disease, and Stroke. Am J Phys Med Rehabil. 2018 Dec;97(12):879-884. doi: 10.1097/PHM.0000000000000991.
Reference Type
BACKGROUND
Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.
Reference Type
BACKGROUND
Ferreira PL, Ferreira LN, Pereira LN. [Contribution for the validation of the Portuguese version of EQ-5D]. Acta Med Port. 2013 Nov-Dec;26(6):664-75. Epub 2013 Dec 20. Portuguese.
Reference Type
BACKGROUND
Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
Reference Type
BACKGROUND
Jung JH, Kim NS. The effect of progressive high-intensity inspiratory muscle training and fixed high-intensity inspiratory muscle training on the asymmetry of diaphragm thickness in stroke patients. J Phys Ther Sci. 2015 Oct;27(10):3267-9. doi: 10.1589/jpts.27.3267. Epub 2015 Oct 30.
Reference Type
BACKGROUND
Angst F, Aeschlimann A, Angst J. The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies. J Clin Epidemiol. 2017 Feb;82:128-136. doi: 10.1016/j.jclinepi.2016.11.016. Epub 2016 Dec 14.
Reference Type
BACKGROUND
Other Identifiers
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RehabGBs
Identifier Type: -
Identifier Source: org_study_id
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NA
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NCT02298114
UNKNOWN
NA
Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.
NCT02292810
UNKNOWN
NA
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
NCT00752440
UNKNOWN
PHASE4
Clinical Safety for the Inspiratory Muscle Training
NCT01952002
COMPLETED
Rehabilitation Program in Patients With Scleroderma
NCT05041868
RECRUITING
NA
Long Term Effects of Inspiratory Muscle Training in Cerebral Palsy
NCT06064292
COMPLETED
NA
Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery
NCT02200198
COMPLETED
NA
Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
NCT02236104
COMPLETED
NA
Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.
NCT06363526
ENROLLING_BY_INVITATION
NA
Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease
NCT04387318
COMPLETED
NA
The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training
NCT03767998
COMPLETED
NA
Swallowing Training in Parkinson's Disease
NCT01131494
COMPLETED
NA
High-Intensity Respiratory Muscle Training in Individuals with Parkinson's Disease
NCT05608941
COMPLETED
NA
Does Residual Muscular Weakness Lead to an Increase in Respiratory Complications in Bariatric Patients?
NCT02037516
COMPLETED
NA
Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
NCT05346705
UNKNOWN
NA
Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure
NCT02600000
UNKNOWN
NA
Home-based Respiratory Training on Swallowing in Stroke
NCT06312319
RECRUITING
NA
Upper Extremity Pattern Exercises and Respiratory Functions
NCT06137534
COMPLETED
NA
Neuromuscular Electroestimulation and Respiratory Muscle Training in Subacute Stroke
NCT02473432
COMPLETED
PHASE4
Respiratory Muscle Functions With Balance and Gait in Stroke Patients
NCT06758791
ENROLLING_BY_INVITATION