Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05461898

RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome

Led by Centro de Reabilitacao do Norte · Updated on 2025-04-04

74

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

Sponsors

C

Centro de Reabilitacao do Norte

Lead Sponsor

A

Aveiro University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Guillain-Barré syndrome (GBS) is a neurological condition that causes inflammation of the peripheral nerves and can lead to long-term disability, including respiratory muscle weakness. This weakness can cause breathing difficulties, trouble clearing secretions, and low ventilation, negatively affecting daily life. Researchers are evaluating the effects of inspiratory muscle training (IMT), a breathing exercise program, on respiratory strength, lung function, fatigue, and quality of life for people with GBS through a randomized controlled trial called RehabGBs. The study involves two groups: one receiving standard inpatient rehabilitation alone and the other receiving the same rehabilitation plus a 6-week IMT program using a handheld electronic device called PowerBreath KH2. Participants will train 5 days a week with IMT sessions consisting of 6 cycles of 30 breaths daily, with the resistance adjusted based on symptoms. The inpatient rehabilitation program includes about 5 hours per day of therapy, five days a week, involving physiotherapy, occupational therapy, speech therapy, psychology, and other supportive care. Participants will take part in assessments during the 6-week program to measure changes in maximal inspiratory and expiratory pressures, peak cough flow, muscle strength, fatigue, independence, and oxygen levels. The study will also determine important clinical thresholds to guide future rehabilitation and examine the prevalence of nighttime breathing problems in GBS patients. Safety and progress will be monitored throughout, with a total participation period of 6 weeks for the intervention.

CONDITIONS

Brief Title

RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosed with Guillain-Barré Syndrome
  • Willing to participate in an inpatient rehabilitation program
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of significant cardiac and musculoskeletal diseases
  • Tracheostomized patients
  • Signs of cognitive impairment
  • Current neoplastic or immunological disease that may prevent participation
  • Participation in any other therapeutic intervention besides standard care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive an inpatient rehabilitation program tailored to their needs, including approximately 5 hours of intervention daily, 5 days a week, for 6 weeks. Some participants also receive inspiratory muscle training using an electronic-controlled valve device during this period.

Daily visits, 5 days per week for 6 weeks

Trial Site Locations

Total: 1 location

1

Centro de Reabilitação do Norte

Vila Nova de Gaia, Portugal, 4405 - 565

Actively Recruiting

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Research Team

M

Miguel P Almeida, MSc

S

Sofia A Viamonte, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Disability and health-related quality of life in Guillain-Barré syndrome during the first two years after onset: a prospective study.

Anette Forsberg, Raymand Press, Ulrika Einarsson...

https://pubmed.ncbi.nlm.nih.gov/16323390

Predictors of respiratory failure in patients with Guillain-Barré syndrome: a systematic review and meta-analysis.

Cameron Green, Tess Baker, Ashwin Subramaniam

https://pubmed.ncbi.nlm.nih.gov/29490222

Effects of respiratory muscle training on pulmonary functions in patients with slowly progressive neuromuscular disease: a randomized controlled trial.

Goksen Kuran Aslan, H Nilgun Gurses, Halim Issever...

https://pubmed.ncbi.nlm.nih.gov/24275453