RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years

• diagnosed with Guillain Barré Syndrome

• willing to participate in an inpatient rehabilitation program

• able to provide informed consent

Locations
Other Locations
Portugal
Centro de Reabilitação do Norte
RECRUITING
Vila Nova De Gaia
Contact Information
Primary
Miguel P Almeida, MSc
miguelalmeida.ft@gmail.com
00351919523101
Backup
Sofia A Viamonte, MSc
00351220901200
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 74
Treatments
Experimental: 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
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Aveiro University
Leads: Centro de Reabilitacao do Norte

This content was sourced from clinicaltrials.gov