PURO - PUlmonary Rehabilitation With O-RAGT Platform
Metabolic Consumption, Cardiorespiratory Effort, Cardiac Autonomic Control and Fatigability During Exoskeleton-assisted (the U&O Suite) sit-to Stand Maneuver and Walking in People With Neurological Diseases With Moderate to Severe Gait Disability.
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- UANGO suite exoskeleton
What it measured
Main measures
Walking meters change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobility
Other measures (12)
Number of repetitions change in one-minute sit to stand test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Average VO2 change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobilityPhysical functionO2 cost of walking change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobilityNet metabolic power change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobilityPhysiological cost index (PCI) change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobilityAverage heart rate change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobilityHeart rate increase change during 4 minute walking test
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Walking and mobilityRating of perceived exertion of lower limbs change before and after each trials
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
FatigueRating of perceived exertion of breath change before and after each trials
Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
FatigueAssessment of device usability at the end of each condition
Baseline (Condition 2) and after 24 hours (Condition 3)
Who could take part
MS (type not specified) · 18 to 90
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Dec 2022
Main results due
Mar 2023
Finished
Mar 2023