Last updated: November 13, 2023
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting
Phase
N/A
Condition
Covid-19
Acute Respiratory Distress Syndrome (Ards)
Respiratory Failure
Treatment
Physical therapy that include a standardized cycling training with no additional functional electrical stimulation
Physical therapy that include a standardized cycling training with functional electrical stimulation
Clinical Study ID
NCT04841746
69HCL21_0354
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- Being hospitalized for rehabilitation because of a severe form of the COVID-19 thatrequired an admission in intensive care unit for acute distress respiratory syndrometreated by mechanical ventilation.
- Being beneficiary of the French social security.
Exclusion
Exclusion Criteria:
- Person requiring supplementation in oxygen > 4 L/min because above this threshold, theoxygen flow is considered to be associated with an increased risk of aerosolizationand further virus spread in patient being contagious;
- Oxygen desaturation during exercise (i.e., SpO2 < 90%) and requiring supplementationin oxygen > 4 L/min.
- Person showing a lower motor neuron disease as defined by the medical research councilscore < 48/60 including hyporeflexia (quadricipital and triceps tendons) and decreasein lower limb sensation.
- Persons showing denervated muscle (including quadriceps, hamstring, gluteus andtriceps) confirmed by electromyography because the electrical stimulations deliveredby the stimulator (i.e., symmetric and rectangular biphasic currents) are notappropriate to restore a pedaling movement;
- Person with osteo-articular disease at lower limbs including reduction in range ofmotion at the hip, knee and ankle preventing cycling pedaling in a sitting position;
- Persons with associated neurologic or psychiatric disease;
- Person with a medical contraindication to intensive rehabilitation;
- Person suffering from suspected or diagnosed epilepsy;
- Person with an implanted device;
- Person included in another ongoing research or during an exclusion period of anotherresearch;
- Adults protected by law (guardianship or curatorship);
- Pregnant women
Study Design
Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Physical therapy that include a standardized cycling training with no additional functional electrical stimulation
Phase:
Study Start date:
June 02, 2021
Estimated Completion Date:
June 04, 2024
Connect with a study center
Hopital Henry Gabrielle
Saint-Genis-Laval, 69230
FranceActive - Recruiting
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