RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome

Recruiting now · Not applicable

Conditions studied: Guillain-Barré Syndrome

In brief

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.

Key facts

Study ID

NCT05461898

Run by

Centro de Reabilitacao do Norte

People needed

74

Starts

2023-01-01

Expected to finish

2026-12-31

Last updated by the study team

2025-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years
• diagnosed with Guillain Barré Syndrome
• willing to participate in an inpatient rehabilitation program
• able to provide informed consent

You may not qualify if…

• 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.

Where it is running

• Centro de Reabilitação do Norte — Vila Nova de Gaia, Portugal (enrolling)

Full record on ClinicalTrials.gov

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