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NCT05757830
PURO - PUlmonary Rehabilitation With O-RAGT Platform
Conditions: Multiple Sclerosis, Spinal Cord Injury, Stroke, Traumatic Brain Damage
Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 20
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Location: Italy
Summary
The goal of this interventional study is to assess differences in the metabolic consumption, the cardiorespiratory effort, the cardiac autonomic adaptation, and fatigability during ADL, such as standing from a chair and walking while wearing an electrically powered exoskeleton in different modes of supports in subjects with neurological diseases with moderate to severe walking impairments.
Eligibility Criteria
Inclusion Criteria:Able to perform 4 minutes of back-and-forth locomotion with assistance or resting periods;Height between 160 and 195 cm;Weight not exceeding 100 kg;Diagnosis of Multiple Sclerosis with moderate to severe disability (5,5 < EDSS < 8,0);Diagnosis of stroke or traumatic brain damage (1 ≤ FAC ≤ 3);Diagnosis of spinal cord injury with neurological level of injury<T2 (3 ≤ WISCI II ≤ 16) with a Asia Impairment Score B, C or D.Able to perform 4 minutes of back-and-forth locomotion with assistance or resting periods;Able to use walker;Exclusion Criteria:Impairments in the upper limbs that do not allow the user to hold the crutches/walker.Skin injuries in the areas where the exoskeleton is in contact with the user.Fractures not solved or bone pathologies in lower limbs in which the use of the exoskeleton could be risky (advanced osteoporosis).Psychiatric or cognitive problems that can interfere with the correct use of the device.Important muscle/joint retractions in lower limbs (Modified Ashworth Scale > 3).Any medical conditions that could interfere with the autonomic cardiovascular control (e.g severe diabetes).Use of beta blocker drugs.Presence of severe cardiovascular diseases.
Source: ClinicalTrials.gov (NCT05757830). StuddyBuddy aggregates publicly available trial information.