RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro de Reabilitacao do Norte

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years

diagnosed with Guillain Barré Syndrome

willing to participate in an inpatient rehabilitation program

able to provide informed consent

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inpatient Rehabilitation

    Other intervention

    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

    Other intervention

    Inspiratory muscle training protocol during 6 weeks with a electronic-controlled valve device

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Inpatient Rehabilitation + Inspiratory Muscle TrainingExperimental treatment 2 interventions
Group B: Inpatient RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in maximal inspiratory pressure

Respiratory muscle strength will be assessed with maximal respiratory pressure tests

Time frame
6 weeks

Secondary outcomes

1

Change in maximal expiratory pressure

Respiratory muscle strength will be assessed with maximal respiratory pressure tests

Time frame
6 weeks
2

Change in Peak cough flow

Peak cough flow is the peak expiratory flow during a cough maneuver and will be measured three times and the best value will be used for analysis, using a hand-held peak flow meter.

Time frame
6 weeks
3

Change in Nocturnal transcutaneous carbon dioxide and peripheral oxygen saturation

Nocturnal transcutaneous carbon dioxide will be recorded simultaneously for one night using a digital transcutaneous (SenTec, Switzerland)

Time frame
6 weeks
4

Change in Medical Research Council - Manual Muscle Testing

This test is performed by applying manual resistance and the score is a sum of the strength of six muscle groups: 1) deltoid; 2) biceps; 3) wrist extensor; 4) iliopsoas; 5) quadriceps femoris; and 6) anterior tibial tested bilaterally, from grade 5 (i.e. the patient an move through the full range of motion against gravity and hold an isometric contraction against maximal resistance for 3 seconds) to grade 0 (i.e. no visible contraction)

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro de Reabilitacao do Norte

Lead sponsor

Aveiro University

Collaborator